Efficacy, Safety, and Tolerability of MoviPrep® Versus GoLYTELY® Bowel Preparation in Hospitalized Patients Undergoing Colonoscopy: a Randomized Control Trial
Phase: PHASE4
Conditions: Bowel Preparation Before Colonoscopy
Sponsor: Yale University

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CLINICAL STUDY PROTOCOL
Interventional Drug or Biologic
General Business
 
Efficacy, Safety, and Tolerability of 
MoviPrep® versus GoLYTELY® bowel 
preparation in hospitalized patients 
undergoing colonoscopy: a randomized 
control trial
 Protocol Number
2000031169
Protocol Version
9/29/2021
v1.2
PRINCIPAL INVESTIGATOR:
Darrick K. Li MD, PhD
Department of Medicine, Section of Digestive Diseases
(203) 285-4506
darrick.li@yale.edu
NCT Number: NCT05054036
Study Phase (1, 2, 3, or 4-postmarketing): 4
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REVISION HISTORY:
Revision #
Version Date
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Synopsis
Primary Objective
The primary objective of this study is whether the use of MoviPrep® in hospitalized patients 
undergoing colonoscopy is non-inferior to GoLYTELY® with respect to rates of adequate bowel 
prep.
Secondary Objective
The secondary objectives of this study are to determine whether MoviPrep® improves tolerability 
of bowel preparation in hospitalized patients and whether it reduces delays in inpatient endoscopy 
and hospital length of stay compared to GoLYTELY®. In addition, we will understand whether 
MoviPrep increases cecal intubation rates and how it may effect intubation and withdrawal times 
in colonoscopy.
Study Duration
Two years
Study Design 
Randomized, parallel assignment, non-inferiority clinical trial
Number of Study Sites
Two study sites:

Yale-New Haven Hospital, York St. Campus (New Haven, CT)

Bridgeport Hospital (Bridgeport, CT)
Study Population
Adult inpatients scheduled to undergo colonoscopy 
Number of Participants
450 patients
Primary Outcome Variables

Bowel preparation quality
Secondary Outcome Variables

Tolerability of bowel preparation

Segmental colon cleansing quality

Rates of “excellent” bowel preparation

Cecal intubation rate

Cecal intubation time

Withdrawal time

Time to endoscopy

Hospital length of stay

Adverse events
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Abbreviations
Abbreviation 
Explanation
PEG
Polyethylene Glycol
BBPS
Boston Bowel Preparation Score
RR
Relative Risk
ECG
Electrocardiogram
FDA
Federal Drug Administration
IRB
Institutional Review Board
UP
Unanticipated Problem
DCF
Data Collection Form
UPIRSOs
Unanticipated Problems Involving Risks to 
Subjects or Others
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Glossary of Terms
Glossary
Explanation
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Table of Contents
Synopsis ..................................................................................................................................3
Abbreviations ...........................................................................................................................4
Glossary of Terms....................................................................................................................5
1
Introduction.......................................................................................................................9
1.1
Introductory Statement ..............................................................................................9
2
Background.....................................................................................................................10
2.1.1
Preclinical Experience......................................................................................10
2.1.2
Clinical Experience...........................................................................................10
2.2
Background/prevalence of research topic ...............................................................10
3
Rationale/Significance ....................................................................................................12
3.1
Problem Statement..................................................................................................12
3.2
Purpose of Study/Potential Impact ..........................................................................12
3.2.1
Potential Risks..................................................................................................12
3.2.2
Potential Benefits .............................................................................................12
4
Study Objectives.............................................................................................................13
4.1
Hypothesis...............................................................................................................13
4.2
Primary Objective ....................................................................................................13
4.3
Secondary Objectives..............................................................................................13
4.4
Exploratory Objectives.............................................................................................13
5
Study Design ..................................................................................................................14
5.1
General Design Description.....................................................................................14
5.1.1
Study Date Range and Duration ......................................................................14
5.1.2
Number of Study Sites .....................................................................................14
5.2
Outcome Variables..................................................................................................14
5.2.1
Primary Outcome Variables .............................................................................14
5.2.2
Secondary Outcome Variables.........................................................................15
5.2.3
Exploratory Outcome Variables........................................................................15
5.3
Study Population .....................................................................................................15
5.3.1
Number of Participants.....................................................................................15
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5.3.2
Eligibility Criteria/Vulnerable Populations.........................................................15
6
Methods..........................................................................................................................17
6.1
Treatment ................................................................................................................17
6.1.1
Identity of Investigational Product ....................................................................17
6.1.2
Dosage, Administration, Schedule ...................................................................17
6.1.3
Method of Assignment/Randomization.............................................................17
6.1.4
Blinding and Procedures for Unblinding...........................................................17
6.1.5
Packaging/Labelling .........................................................................................18
6.1.6
Storage Conditions...........................................................................................18
6.1.7
Concomitant therapy ........................................................................................18
6.1.8
Restrictions.......................................................................................................18
6.2
Assessments ...........................................................................................................18
6.2.1
Efficacy.............................................................................................................18
6.2.2
Safety Monitoring .............................................................................................19
6.2.3
Adverse Events Definition and Reporting.........................................................19
6.2.4
Pharmacokinetics.............................................................................................20
6.2.5
Biomarkers .......................................................................................................20
6.3
Study Procedures....................................................................................................21
6.3.1
Study Schedule ................................................................................................21
6.3.2
Informed Consent.............................................................................................21
6.3.3
Screening .........................................................................................................21
6.3.4
Enrollment ........................................................................................................21
6.3.5
On Study Visits.................................................................................................21
6.3.6
End of Study and Follow-up .............................................................................22
6.3.7
Removal of subjects.........................................................................................22
6.4
Statistical Methods ..................................................................................................22
6.4.1
Statistical Design..............................................................................................22
6.4.2
Sample Size Considerations ............................................................................22
6.5
Planned Analyses....................................................................................................23
6.5.1
Primary Objective Analysis...............................................................................23
6.5.2
Secondary Objectives Analyses.......................................................................23
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6.5.3
Exploratory Objectives Analyses......................................................................23
6.5.4
Safety ...............................................................................................................23
6.5.5
Analysis of Subject Characteristics ..................................................................23
6.5.6
Interim Analysis ...............................................................................................24
6.5.7
Health economic evaluation .............................................................................24
6.5.8
Other ................................................................................................................24
6.5.9
Subsets and Covariates ...................................................................................24
6.5.10
Handling of Missing Data .................................................................................25
7
Trial Administration.........................................................................................................26
7.1
 Ethical Considerations: Informed Consent/Assent and HIPAA Authorization ........26
7.2
Institutional Review Board (IRB) Review.................................................................26
7.3
Subject Confidentiality.............................................................................................26
7.4
Deviations/Unanticipated Problems.........................................................................27
7.5
Data Collection ........................................................................................................27
7.6
Data Quality Assurance...........................................................................................28
7.7
Study Records.........................................................................................................28
7.8
Access to Source Documents .................................................................................28
7.9
Data or Specimen Storage/Security ........................................................................28
7.10
Retention of Records...............................................................................................28
7.11
Study Monitoring......................................................................................................29
7.12
Data Safety Monitoring Plan....................................................................................29
7.13
Study Modification ...................................................................................................30
7.14
Study Discontinuation..............................................................................................30
7.15
Study Completion ....................................................................................................30
7.16
Conflict of Interest Policy.........................................................................................30
7.17
Funding Source .......................................................................................................31
7.18
Publication Plan.......................................................................................................31
8
Appendices.....................................................................................................................32
9
List of Tables ..................................................................................................................33
10
References..................................................................................................................34
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1 Introduction
1.1
Introductory Statement
This document is a protocol for a human research study. The purpose of this protocol is to 
ensure that this study is to be conducted according to ICH GCP guidelines, and according to 
CFR 21 Part 312, other applicable government regulations and Institutional research policies 
and procedures.
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2 Background
2.1.1
Preclinical Experience
MoviPrep [1] is a polyethylene glycol (PEG)-based bowel cleansing preparation that is 
approved for the use in adults preparing for colonoscopy. It uses several osmotic agents – 
PEG-3350 (200 g), sodium sulfate (15 g), ascorbic acid (9.4 g) and sodium ascorbate (11.8 g) 
administered in a 2 liter (approximately ½ gallon) electrolyte solution to retain fluid within the 
bowel lumen and cause an osmotic diarrhea. PEG-3350 is a nonabsorbable polymer that 
holds co-administered fluid within the colonic lumen. Ascorbic acid in quantities exceeding the 
intestine’s absorptive capacity draws extracellular fluid across the bowel wall and keeps 
ingested fluids in the lumen. Sodium sulfate has a similar effect; because most oral sulfate is 
not absorbed, an electrochemical gradient is established that limits sodium absorption and 
promotes fluid efflux into the gut lumen. GoLYTELY [2] is a combination of PEG-3350 and 
electrolytes supplied in a 4-liter (approximately one gallon) disposable jug containing PEG-
3350 (236 g), sodium sulfate (22.74 g), sodium bicarbonate (6.74 g), sodium chloride (5.86 g), 
and potassium chloride (2.97 g). GoLYTELY functions in similar manner to promote an 
osmotic diarrhea but requires a large volume of liquid which must be ingested. Given the 
significant clinical experience with GoLYTELY, it has been considered the standard bowel 
preparation to be used prior to colonoscopy for many years. For both bowel preparations, 
onset of effects occurs within 1 to 2 hours of ingestion. They both do not undergo hepatic or 
renal metabolism as the primary agent (PEG-3350) is not absorbed.
2.1.2
Clinical Experience
Multiple clinical trials have compared MoviPrep’s efficacy and tolerability to existing bowel 
preparations. One randomized study of 308 patients compared 2L of MoviPrep with 4L of 
GoLYTELY and found that cleansing was considered effective in 88.9% and 94.8% of patients, 
respectively [3]. Moreover, patients rated MoviPrep as more tolerable, better tasting and easier 
to consume the entire dose. In another study, MoviPrep was compared to a low volume bowel 
preparation comprised of 238g Miralax in 64 oz of Gatorade along with bisacodyl in a 
randomized study of 150 patients [4]. In this study, MoviPrep was associated with significantly 
higher rates of high quality bowel cleansing of the right (84.6% vs. 61.6%) and transverse 
colon (86.4% vs. 72.1%) compared to the Miralax/Gatorade/Biscodyl preparation. Finally, 
MoviPrep has been compared to another low volume bowel prep, Suprep (oral sulfate 
solution), in a randomized study of 187 patients and was found to have similar rates of 
successful bowel cleansing (88.3% vs. 86%) without significant difference in patient-reported 
palatability, tolerability, or adverse events [5]. With regard to administration schedule, a meta-
analysis assessing split versus single dosing of MoviPrep found both regimens demonstrated 
high rates of bowel cleansing efficacy, with success rates of 87.4% in the split-dose group and 
73.4% in the single-dose group, suggesting that split-dosing of MoviPrep (1L the evening prior 
to colonoscopy, 1L the morning of colonoscopy) [6]. Moreover, a recent systematic review and 
meta-analysis of the tolerability and efficacy of low- and high-volume split dose regimens for 
bowel cleansing prior to colonoscopy demonstrated that low-volume split-dose regimens had 
higher odds for compliance or completion and tolerability without significant differences in 
adequacy of bowel cleansing [7]. Together, these findings strongly suggest that split-dosing 
of MoviPrep and GoLYTELY should be the preferred administration schedule for maximum 
efficacy and tolerability prior to colonoscopy.
2.2
Background/prevalence of research topic
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Adequate bowel cleansing is a critical component in the care of hospitalized patients 
undergoing diagnostic or therapeutic colonoscopy. Some factors that have been consistently 
associated with inadequate bowel preparation are inpatient status, older age, non-adherence 
to preparation instructions, constipation as a colonoscopy indication, and history of 
stroke/dementia [8, 9]. Inadequate bowel preparation is also associated with worse clinical 
outcomes, including increased rates of complications, missed pathologic lesions, repeated 
bowel preparation medication administration, and even aborted colonoscopy procedures [10-
15]. This can result in increased hospital length of stay (LOS) and healthcare costs [10, 16]. 
An estimated 30-50% of inpatients undergoing colonoscopy suffer from inadequate colon 
cleansing [17, 18]. According to a survey of 545 colonoscopies performed at Yale-New Haven 
Hospital between July 2018 and June 2020, 29.9% were determined to be suboptimal (defined 
as physician rating of poor, inadequate, unsatisfactory or a Boston Bowel Preparation Score 
(BBPS) <5). Given the frequency of inadequate bowel preparation among hospitalized 
patients, significant healthcare resources are expended by delays stemming from poor 
preparation. However, few strategies have been rigorously shown to reduce the risk of 
inadequate bowel preparation and delays in inpatient colonoscopy [19-21].
 
One patient-centered reason for inadequate preparation is the inability to complete the bowel 
regimen as prescribed, secondary to patient discomfort or difficulty consuming the amount of 
fluid required. GoLYTELY (polyethylene glycol + electrolytes) requires the patient to consume 
4 liters of fluids (approximately one gallon) in a single- or split-dosing regimen. However, a 
recent meta-analysis evaluating the efficacy and tolerability of low- vs. high-volume bowel 
cleansing regimens demonstrated no significant difference between the adequacy of the 
cleansing (RR 1.00, CI 0.98-1.02) or in adenoma detection rate (RR 0.96, CI 0.87-1.08). 
However, there was a higher odds ratio for compliance or completion (RR 1.06, CI 1.02-1.1), 
tolerability (RR 1.39, CI 1.12-1.74) and willingness to repeat the bowel preparation (RR 1.41, 
CI 1.12-1.74) associated with the low-volume preparations. There were no significant 
differences found when evaluating adverse effects [7].
MoviPrep (polyethylene glycol + ascorbic acid) is a low-volume bowel preparation, requiring 
2.8 liters of fluid (approximately 0.7 gallons) in a split-dosing regimen. Most studies have found 
MoviPrep to be non-inferior to split-dose GoLYTELY, as split dosing is recommended in 
colonoscopy guidelines for increased safety and efficacy. As such, we are interested in 
assessing the use of MoviPrep in hospitalized patients and determine if it is non-inferior to 
GoLYTELY with respect to rates of adequate bowel prep but with improved tolerability and 
decreased delays in inpatient endoscopy.
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3 Rationale/Significance
3.1
Problem Statement
Adequate bowel cleansing is a critical component in the care of hospitalized patients 
undergoing diagnostic or therapeutic colonoscopy. However, inpatient status is a well-
established risk factor for inadequate bowel preparation. Inadequate bowel preparation is 
associated with worse clinical outcomes, including increased rates of complications, missed 
pathologic lesions, repeated bowel preparation medication administration, and even aborted 
colonoscopy procedures. However, few strategies have been rigorously shown to reduce the 
risk of inadequate bowel preparation and delays in inpatient colonoscopy.
3.2
Purpose of Study/Potential Impact
In this study, we plan to assess the use of a low volume bowel preparation, MoviPrep, in 
hospitalized patients and determine if it is non-inferior to standard high volume bowel 
preparation, GoLYTELY, with respect to rates of adequate bowel prep but with improved 
tolerability and decreased delays in inpatient endoscopy. This may lead to improved 
tolerability of bowel preparation among hospitalized patients as well as improved bowel 
preparation, which may lead to fewer patient complications as well as decreased hospital 
length of stay and expenditures.
3.2.1
Potential Risks
The potential risks incurred with the study include those associated with the clinically 
warranted procedure (i.e. colonoscopy), including bleeding, infection, missed lesion, and 
bowel perforation requiring surgical intervention. With the bowel preparations, there may some 
additional risk which are summarized as follows. With both MoviPrep and GoLYTELY, there 
is the risk of adverse reactions including malaise, nausea, abdominal pain (>10% of patients 
reported), as well as dyspepsia, upper abdominal pain and vomiting (1-10% of patients 
reported). Fluid and serum electrolyte abnormalities may occur which may also be associated 
with cardiac arrhythmias, seizures, renal impairment, ischemic colitis, and aspiration. To 
minimize risk, baseline and post-procedure electrolytes, BUN and creatinine will be monitored 
in patients at risk for renal impairment, seizure, or who have a history of electrolyte 
abnormality. In addition, a baseline and post-procedure electrocardiogram (ECG) for patients 
with risks for prolonged QT or arrhythmias will be performed. As the patients will be in the 
hospitalized setting, routine care and monitoring for physicians and nurses will also continue. 
3.2.2
Potential Benefits
Anticipated direct benefits to participants include potentially decreased symptoms of nausea, 
bloating and abdominal cramping if randomized to the MoviPrep arm of the trial. Aside from 
this, potential direct benefits to society at large include decreased hospital length of stay and 
expenditures because of increased tolerability of a lower volume bowel preparation in 
hospitalized patients.
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4 Study Objectives
4.1
Hypothesis
We hypothesize that among hospitalized adult patients who are scheduled for colonoscopy, 
the use of MoviPrep will be non-inferior to GoLYTELY in the rates of adequate of bowel 
preparation. We also hypothesize that MoviPrep will be better tolerated than GoLYTELY and 
will be associated with decreased time to endoscopy.
4.2
Primary Objective
The primary objective of this study is to determine whether MoviPrep (polyethylene glycol, 
electrolytes, ascorbic acid) is non-inferior to GoLYTELY (polyethylene glycol, electrolytes) for 
bowel cleansing in hospitalized adult patients who are scheduled for colonoscopy. An 
adequate bowel preparation will be defined as a BBPS ≥6 with no segment scoring less than 
2. The BBPS is a validated scoring tool that assesses the three segments of the colon and 
rates them from 1-3 based on the ability to visualize the mucosa [22].
4.3
Secondary Objectives
The secondary objectives of this study are to compare the tolerability of MoviPrep compared 
to GoLYTELY, to determine the impact of MoviPrep on segmental cleansing (right, transverse, 
and left colon), cecal intubation rates, intubation/withdrawal time compared to GoLYTELY, 
and to determine if use of MoviPrep influences hospital length of stay or time to colonoscopy 
in hospitalized adult patients who are scheduled for colonoscopy. Tolerability will be assessed 
using the validated Mayo Clinic Bowel Prep Questionnaire [23].
4.4
Exploratory Objectives
N/A.
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5 Study Design
5.1
General Design Description
This study will be a single-blind (to the outcomes assessor), parallel assignment, randomized, 
non-inferiority trial comparing the rates of adequate bowel preparation in hospitalized adult 
patients undergoing bowel preparation for colonoscopy with either a low-volume bowel 
preparation (MoviPrep) or a traditional high-volume bowel preparation (GoLYTELY). While the 
endoscopist and the patient will not be blinded to the nature of the randomization, a central 
outcomes assessor that will be scoring the adequacy of the colonoscopy preparation via the 
BBPS will be blinded to the bowel preparation used. 
Figure 1. Trial design
5.1.1
Study Date Range and Duration
Two and a half years (approximately January 2022 to July 2024)
5.1.2
Number of Study Sites
Two study sites:
1.
Yale-New Haven Hospital, York St. Campus (New Haven, CT)
2.
Bridgeport Hospital (Bridgeport, CT)
5.2
Outcome Variables
5.2.1
Primary Outcome Variables
The primary outcome of this study is the rate of adequate bowel preparation prior to 
colonoscopy. An adequate bowel preparation will be defined as a BBPS ≥6 with no segment 
scoring less than 2. The BBPS is a validated scoring tool that assesses the three segments 
of the colon and rates them from 1-3 based on the ability to visualize the mucosa [22]. This 
has been a standard primary outcome for many bowel preparation studies since the 
development of the BBPS.
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5.2.2
Secondary Outcome Variables
Several secondary outcomes will be evaluated as part of this study. These include:
-
Tolerability of bowel preparation, assessed using the Mayo Bowel Preparation 
Questionnaire [23].
-
Segmental colon cleansing, defined as BBPS component score given to the right 
colon, transverse colon, and left colon on withdrawal.
-
Rates of “excellent” bowel preparation, defined by a BBPS of 8 or 9.
-
Rates of cecal intubation, defined by percentages of colonoscopies that reach the 
cecum.
-
Cecal intubation time, defined by time in minutes from insertion of the colonoscope 
into the rectum to reaching the cecum.
-
Withdrawal time, defined by time from reaching the cecum to completion of 
examination.
-
Time to endoscopy, defined as time from initial consultation to start of colonoscopy.
-
Hospital length of stay
5.2.3
Exploratory Outcome Variables
N/A.
5.3
Study Population
Hospitalized adult patients (≥18 years of age) scheduled to undergo colonoscopy.
5.3.1
Number of Participants
Number of participants anticipated to be screened and/or enrolled by site:
Site
# Screened
# Enrolled
Yale New Haven Hospital, York St. Campus
400
320
Bridgeport Hospital
160
128
Total
560
458
5.3.2
Eligibility Criteria/Vulnerable Populations
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria:
1.
Provision of signed and dated informed consent form
2.
Stated willingness to comply with all study procedures and availability for the duration 
of the study 
3.
Male or female, aged 18 or greater
4.
Hospitalized patient scheduled to undergo colonoscopy with bowel preparation (not 
including preparation with enemas alone)
5.
Ability to take bowel preparation and be willing to adhere to the regimen
An individual who meets any of the following criteria will be excluded from participation in 
this study:
1.
Patients presenting to the hospital with ileus, toxic megacolon, evidence of 
gastrointestinal obstruction
2.
Receipt of bowel preparation for other reasons during their hospitalization prior to their 
colonoscopy
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3.
Patients with prior significant gastrointestinal surgeries including colonic resection, 
subtotal colectomy, abdomino-perineal resection, Hartmann’s procedure or other 
similar surgeries involving structure/function of small intestine or colon
4.
Unable to give informed consent to the procedure
5.
Known glucose-6-phosphate dehydrogenase deficiency
6.
Known phenylketonuria 
7.
Known hypersensitivity to polyethylene glycols or ascorbic acid
8.
Patients undergoing colonoscopy for foreign body removal and/or decompression
9.
Pregnancy or lactating women
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6 Methods
6.1
Treatment 
6.1.1
Identity of Investigational Product
The test product is MoviPrep (polyethylene glycol 3350, sodium sulfate, sodium chloride, 
potassium chloride, sodium ascorbate, ascorbic acid). This is a Federal Drug Administration 
(FDA)-approved oral bowel preparation for the purposes of cleansing of the colon in 
preparation for colonoscopy in adults.
The active control is GoLYTELY (polyethylene glycol 3350 + electrolytes). This is also an FDA-
approved oral bowel preparation for the purposes of cleansing of the colon in preparation for 
colonoscopy in adults.
6.1.2
Dosage, Administration, Schedule 
For MoviPrep, the dose, schedule, and route of administration are as follows:

On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total 
volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 
oz. of clear liquids before bed.

On the morning of the procedure, repeat the above steps and make sure all fluids are 
consumed at least 2 hours prior to colonoscopy.

Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for 
dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first 
MoviPrep dose.

Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
For GoLYTELY, the dose, schedule, and route of administrate are as follows:

On the evening prior to the colonoscopy, mix powder with lukewarm water to a total 
volume of 4 liters (approximately one gallon). Drink 2 liters (approximately ½ gallon) of 
the solution and store the rest in the refrigerator.

Drink the remaining 2 liters (approximately ½ gallon) on the morning of the procedure.

Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by 
only clear liquids until the procedure is complete.

Avoid red and purple liquids.
6.1.3
Method of Assignment/Randomization 
Randomization will occur at the time when the bowel preparation for upcoming colonoscopy. 
A computer-generated randomization list stratified by center will be used. Patients will be 
centrally randomized in a 1:1 manner with the randomized list being created and held by the 
hospital pharmacy. When the bowel preparation is ordered, the hospital pharmacy will be 
contacted and will assign and provide the correct treatment for the enrolled patient so the 
investigator or the coordinator will not be involved in allocation. 
6.1.4
Blinding and Procedures for Unblinding 
The outcomes assessor (see Section 6.2.1 for details) will be formally blinded as they will 
receive a de-identified video recording of the colonoscopy itself and will judge the adequacy 
of the bowel preparation. The patient will not be blinded in this case as the differences in the 
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volume of bowel preparation will make blinding impossible. The endoscopist will be 
encouraged to avoid looking at the medication administration records or asking the patient 
regarding the bowel preparation but will not be formally blinded. 
6.1.5
Packaging/Labelling
MoviPrep is supplied as a single-use carton containing a disposable container for 
reconstitution and 4 pouches of powdered drug labelled Pouch A (2) and Pouch B (2).
GoLYTELY is supplied in powdered form in a disposable jug or packet.
6.1.6
Storage Conditions
MoviPrep should be stored at 68-77°F with excursions permitted at 59 to 86°F. When 
reconstituted, keep solution refrigerated and use within 24 hours.
GoLYTELY should be stored in a sealed container at 5-86°F. When reconstituted, keep 
solution refrigerated and use within 48 hours.
6.1.7
Concomitant therapy
No restrictions.
6.1.8
Restrictions
No restrictions.
6.2
Assessments
6.2.1
Efficacy
The primary assessment of efficacy in this study is the frequency of adequate bowel 
preparation prior to colonoscopy associated with each arm. An adequate bowel preparation 
will be defined as a BBPS ≥6 with no segment scoring less than 2. The BBPS is a validated 
scoring tool that assesses the three segments of the colon and rates them from 1-3 based on 
the ability to visualize the mucosa [22] and has been a standard primary outcome for many 
bowel preparation studies since the development of the BBPS.
The assessment of bowel preparation quality will be determined through review of de-
identified video recordings of the colonoscopy of enrolled patients. Recording the colonoscopy 
will not add any extra time to the procedure. All images and videos will be recorded without 
any patient identifier and uploaded onto a Yale Secure Box folder based on the patient, 
endoscopist, and center identification numbers. These recordings will be accessed by 
dedicated central reviewers who will score the quality of the bowel preparation on withdrawal 
via the BBPS. BBPS scoring will be recorded on a form that will be provided to the central 
reviewers (Appendix 1). 
The secondary outcome of tolerability of the bowel preparation will be assessed using the 
Mayo Clinic Bowel Preparation Questionnaire [23] (Appendix 2). The answers to each of the 
nine questions will be tabulated and compared between the two arms of the trial.  
Additional secondary outcomes of cecal intubation rate, cecal intubation time, withdrawal time 
will be determined during the procedure by recording whether or not the cecum was reached 
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during the colonoscopy (as identified by the visualization of the appendiceal orifice and the 
ileocecal valve), the time from insertion of the colonoscope to cecal intubation, and the time 
from cecal intubation to complete withdrawal of the colonoscopy, respectively.
The secondary outcome of time to endoscopy will be calculated as the time from bowel 
preparation order to the start of the colonoscopy.
The secondary outcome of hospital length of stay will be assessed at time of patient discharge.
6.2.2
Safety Monitoring
To monitor and evaluate the safety of the intervention, we will perform the following 
monitoring tests:
Prior to bowel preparation:

Electrolytes, BUN, creatinine

ECG
Post-procedure:

Electrolytes, BUN, creatinine

ECG
6.2.3
Adverse Events Definition and Reporting
Definitions
Adverse event (AE) means any untoward medical occurrence associated with the use of an 
intervention in humans, whether or not considered intervention-related (21 CFR 312.32 (a)).
An AE or suspected adverse reaction is considered "serious" (SAE) if, in the view of either the 
investigator or sponsor, it results in any of the following outcomes: 

death, 

a life-threatening adverse event, 

prolongation of existing hospitalization, 

a persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions, or

An important medical event that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical 
judgment, they may jeopardize the participant and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. Examples of such 
medical events include allergic bronchospasm requiring intensive treatment in an 
emergency room or at home, blood dyscrasias or convulsions that do not result in 
inpatient hospitalization, or the development of drug dependency or drug abuse.
Severity
Adverse events will be graded according to Common Terminology Criteria for Adverse Events 
v5.0. For AEs not included in the protocol defined grading system, the following guidelines will 
be used to describe severity. 

Mild – Events require minimal or no treatment and do not interfere with the participant’s 
daily activities. 

Moderate – Events result in a low level of inconvenience or concern with the 
therapeutic measures. Moderate events may cause some interference with 
functioning.
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
Severe – Events interrupt a participant’s usual daily activity and may require systemic 
drug therapy or other treatment. Severe events are usually potentially life-threatening 
or incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”.]
Relationship to Investigational Product
All AEs must have their relationship to study intervention assessed by the clinician who 
examines and evaluates the participant based on temporal relationship and his/her clinical 
judgment. The degree of certainty about causality will be graded using the categories below. 
In a clinical trial, the study product must always be suspect.

Definitely Related – There is clear evidence to suggest a causal relationship, and other 
possible contributing factors can be ruled out. The clinical event, including an abnormal 
laboratory test result, occurs in a plausible time relationship to study intervention 
administration and cannot be explained by concurrent disease or other drugs or 
chemicals. The response to withdrawal of the study intervention (dechallenge) should 
be clinically plausible. The event must be pharmacologically or phenomenologically 
definitive, with use of a satisfactory rechallenge procedure if necessary.

Probably Related – There is evidence to suggest a causal relationship, and the 
influence of other factors is unlikely. The clinical event, including an abnormal 
laboratory test result, occurs within a reasonable time after administration of the study 
intervention, is unlikely to be attributed to concurrent disease or other drugs or 
chemicals, and follows a clinically reasonable response on withdrawal (dechallenge). 
Rechallenge information is not required to fulfill this definition.

Potentially Related – There is some evidence to suggest a causal relationship (e.g., 
the event occurred within a reasonable time after administration of the trial medication). 
However, other factors may have contributed to the event (e.g., the participant’s clinical 
condition, other concomitant events). Although an AE may rate only as “possibly 
related” soon after discovery, it can be flagged as requiring more information and later 
be upgraded to “probably related” or “definitely related”, as appropriate.

Unlikely to be related – A clinical event, including an abnormal laboratory test result, 
whose temporal relationship to study intervention administration makes a causal 
relationship improbable (e.g., the event did not occur within a reasonable time after 
administration of the study intervention) and in which other drugs or chemicals or 
underlying disease provides plausible explanations (e.g., the participant’s clinical 
condition, other concomitant treatments).

Not Related – The AE is completely independent of study intervention administration, 
and/or evidence exists that the event is definitely related to another etiology. There 
must be an alternative, definitive etiology documented by the clinician.
Expectedness
The Principal Investigator will be responsible for determining whether an AE is expected or 
unexpected.  An AE will be considered unexpected if the nature, severity, or frequency of the 
event is not consistent with the risk information previously described for the study intervention.
Reporting
Adverse event reports will be submitted to the IRB by the Principal Investigator in accordance 
with the respective IRB procedures. Applicable adverse events will be reported to the IRB as 
soon as possible and, in no event, later than 5 business days following the primary investigator 
receipt of the respective information.  
6.2.4
Pharmacokinetics
N/A.
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6.2.5
Biomarkers
N/A.
6.3
Study Procedures
6.3.1
Study Schedule
There will be a total of 4 visits as part of the study. An initial visit while the individual is in the 
hospital for standard of care procedure, we will conduct screening and consent, a second visit 
after completion of the bowel preparation and before the colonoscopy during which the bowel 
preparation questionnaire is administered, a third visit during which the colonoscopy is 
performed as standard of care, and a follow-up visit post-procedure as per standard of care 
at each center to assess interim events.
Table 1. Study Schedule
Screening
Treatment
Follow-up
Time
Before bowel preparation
After bowel preparation
During colonoscopy
1-3 days
Procedures & 
Activities
- Assess patient eligibility 
from medical records
- Informed consent
- Randomize patient
- Administer bowel 
preparation 
questionnaire
- Assess bowel 
preparation quality
- Follow-up visit per 
standard of care at each 
center
- Assessment of interim 
events
Data Collection
- Patient characteristics
- Tolerability
- Complications
- Recording and 
assessment of bowel 
preparation quality
- Procedure 
characteristics
- Complications
6.3.2
Informed Consent
Informed consent will be obtained for the purposes of recruitment of patients to this study. 
Non-English-speaking subjects will be invited with the use of a translator. If the patient is 
cognitively impaired, their legally authorized representative will be approached for consent. 
The study will be explained to the prospective subject and they will be allowed ample time to 
determine if they want to participate in the study. At that time, they will be asked to sign the 
consent form. If subjects initially enrolled via a legally authorized representative regains 
decisional capacity before the completion of their participation in their study, informed consent 
will be obtained from the subject.
6.3.3
Screening
Screening for potential subjects will be performed by a member of the study team (which 
includes the Principal Investigator, co-investigators, and research coordinators). Patients 
being evaluated by the General GI and Advanced Endoscopy consultation team who are 
planned to undergo colonoscopy will be screened by review of medical records. 
6.3.4
Enrollment 
Enrollment in the study will take place after they have been screened and meet eligibility 
criteria and have been consented. Subjects will be consented during an in-person visit in the 
patient’s hospital room by a member of the study team. Subjects will be given at minimum 30 
minutes to decide upon their participation in the study and will more than likely have several 
hours to do so.
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6.3.5
On Study Visits
Study Visit 1 (prior to bowel preparation):
-
Informed consent
-
Randomization
Study Visit 2 (after bowel preparation, before colonoscopy)
-
Administration of the Mayo Clinic Bowel Preparation Questionnaire (for research 
purposes)
-
Assessment for adverse events and complications from bowel preparation (standard 
of care)
Study Visit 3 (colonoscopy)
-
Colonoscopy (standard of care)
-
Video recording of colonoscopy and assessment of bowel preparation quality by 
central reviewer (for research purposes)
-
Procedure characteristics (standard of care)
Study Visit 4 (1-3 days post-procedure)
-
Assessment for adverse events and complications from procedure (standard of care)
6.3.6
End of Study and Follow-up
The study will be completed for the patient once Study Visit 4 (1-3 days post-procedure) has 
occurred. Results of the colonoscopy will be shared with the inpatient primary team as per 
standard of care. Data regarding length of hospital stay for each subject will be collected but 
will be done so retrospectively without the need for an additional follow-up visit. 
6.3.7
Removal of subjects
Subjects may withdraw their consent for the use of their data at any time, if the material or 
data is identifiable, by calling the Principal Investigator or a member of the research team. In 
this event, the Principal Investigator will indicate in the database that consent from the subject 
is no longer active.
Data that was collected before the subject withdrew their consent may still be used to complete 
the research that has already commenced. The researchers will anonymize the data by 
removing and destroying all identifiers and links to identifiers so that it can never be associated 
with the subject, but the researchers will not destroy the data.
6.4
Statistical Methods
6.4.1
Statistical Design
Continuous variables will be described as mean and standard deviation while categorical 
variables will be described as percentages. A 2-sided student’s t test will be used to compare 
the means of continuous variables and a chi-squared test was used to compare categorical 
variables. Results from the patient tolerability questionnaire were pooled and compared 
between treatment arms using the chi-square test. Univariate and multivariate logistic 
regression will be performed to determine factors that are associated with adequate bowel 
preparation. A p-value of <0.05 will be considered statistically significant.
6.4.2
Sample Size Considerations
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A sample size estimation of 219 patients per arm was determined based on expected overall 
cleansing rates of 85% for both arms, a noninferiority margin of 10%, power of 90%, and a 5% 
significance level. Thus, with an anticipated 80% rate of enrollment and minimal anticipated 
dropout rate, we would anticipate needing to screen a total of 550 patients. Because the 
primary outcome measure will be assessed based on video recording of the standard of care 
colonoscopy, we do not anticipate any dropouts.
6.5
Planned Analyses
6.5.1
Primary Objective Analysis
The primary assessment of efficacy in this study is the frequency of adequate bowel 
preparation prior to colonoscopy associated with each arm. An adequate bowel preparation 
will be defined as a Boston Bowel Preparation Score (BBPS) ≥6 with no segment scoring less 
than 2. The BBPS is a validated scoring tool that assesses the three segments of the colon 
and rates them from 1-3 based on the ability to visualize the mucosa [22] and has been a 
standard primary outcome for many bowel preparation studies since the development of the 
BBPS.
The assessment of bowel preparation quality will be determined through review of de-
identified video recordings of the colonoscopy of enrolled patients. These video recordings will 
be uploaded onto a Yale Secure Box folder and will be accessed by dedicated central 
reviewers who will score the quality of the bowel preparation on withdrawal via the BBPS. 
BBPS scoring will be recorded on a form that will be provided to the central reviewers 
(Appendix 1). 
6.5.2
Secondary Objectives Analyses
The secondary outcome of tolerability of the bowel preparation will be assessed using the 
Mayo Clinic Bowel Preparation Questionnaire [23] (Appendix 2). The answers to each of the 
nine questions will be tabulated and compared between the two arms of the trial.  
Additional secondary outcomes of cecal intubation rate, cecal intubation time, withdrawal time 
will be determined during the procedure by recording whether the cecum was reached during 
the colonoscopy (as identified by the visualization of the appendiceal orifice and the ileocecal 
valve), the time from insertion of the colonoscope to cecal intubation, and the time from cecal 
intubation to complete withdrawal of the colonoscopy, respectively.
The secondary outcome of time to endoscopy will be calculated as the time from bowel 
preparation order to the start of the colonoscopy.
The secondary outcome of hospital length of stay will be assessed at time of patient discharge.
Adverse events and complications will be summarized descriptively and be analyzed as 
described in Section 6.4.1.
6.5.3
Exploratory Objectives Analyses
N/A.
6.5.4
Safety 
Safety analysis will be performed as described in Sections 6.4.1 and 6.5.2.
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6.5.5
Analysis of Subject Characteristics
For baseline characteristics, continuous variables will be described as mean and standard 
deviation while categorical variables will be described as percentages. The following 
characteristics will be collected:

Demographics
o
Age
o
Sex
o
Race
o
Ethnicity

Clinical Characteristics
o
Body Mass Index
o
Indication for colonoscopy
o
ASA class
o
Charlson comorbidity scale

Medical Comorbidities
o
Hypertension
o
Diabetes Mellitus
o
Malignancy
o
Chronic Kidney Disease
o
Cirrhosis
o
Dementia

Medications
o
Opioids
o
Tricyclic antidepressants
o
Antithrombotics
o
Anti-hypertensives

Laboratory Tests at baseline
o
Sodium
o
Potassium
o
BUN
o
Creatinine
o
Glucose
o
Hemoglobin
o
Platelets
o
PT
o
INR
6.5.6
Interim Analysis
N/A.
6.5.7
Health economic evaluation
We will also plan a cost-effectiveness analysis comparing the overall hospital expenditures in 
patients receiving MoviPrep and GOLYTELY. 
6.5.8
Other
No other additional analyses will be performed.
6.5.9
Subsets and Covariates
Safety and efficacy outcomes will be assessed in the following subgroups:
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
Patients on prescribed narcotics

Patients with chronic kidney disease

Age >65

Age >75

Patients with admission primarily for assessment of gastrointestinal disease (i.e. 
gastrointestinal bleeding, inflammatory bowel disease, diarrhea, iron deficiency 
anemia)
6.5.10 Handling of Missing Data
Missing outcome data will not be included in the final analysis. 
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7  Trial Administration
7.1
 Ethical Considerations: Informed Consent/Assent and HIPAA Authorization
Informed consent and HIPAA authorization will be obtained for the purposes of recruitment of 
patients to this study. Non-English-speaking subjects will be invited with the use of a translator. 
If the patient is cognitively impaired, their legal representative will be approached for consent. 
No payment will be provided for participation. It is possible that a previously unknown condition 
will be discovered as the result of the study procedure but no data will be collected on this as 
part of the study. 
7.2
Institutional Review Board (IRB) Review
The protocol will be submitted to the IRB for review and approval. Approval of the protocol 
must be obtained before initiating any research activity. Any change to the protocol or study 
team will require an approved IRB amendment before implementation.  The IRB will determine 
whether informed consent and HIPAA authorization are required.  
The IRB will conduct continuing review at intervals appropriate to the degree of risk, but not 
less than once per year. A study closure report will be submitted to the IRB after all research 
activities have been completed. Other study events (e.g. data breaches, protocol deviations) 
will be submitted per the Yale IRB's policies.
7.3
Subject Confidentiality
Participant confidentiality and privacy is strictly held in trust by the participating investigators 
and their staff. This confidentiality is extended to cover testing of biological samples and 
genetic tests in addition to the clinical information relating to participants. Therefore, the study 
protocol, documentation, data, and all other information generated will be held in strict 
confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval. All research activities will be conducted 
in as private a setting as possible.
Representatives of the IRB, regulatory agencies or study sponsor/funding agency may inspect 
all documents and records required to be maintained by the investigator for the participants in 
this study. The study site will permit access to such records.
The study participant's contact information will be securely stored at each study site for internal 
use during the study. At the end of the study, all records will continue to be kept in a secure 
location for as long a period as dictated by the reviewing IRB, Institutional policies, regulatory, 
or sponsor/funding agency requirements.
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored on a REDCap (Research Electronic Capture) 
database or a Yale Secure Box folder. This will not include the participant's contact or 
identifying information. Rather, individual participants and their research data will be identified 
by a unique study identification number. Subject medical record review will be limited to just 
the elements needed to complete the study. A master list linking the unique study number to 
the human subject will be maintained in a locked drawer in LMP 1080 at the Yale School of 
Medicine.
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The study data entry and study management systems used will be secured and password 
protected. Only authorized HIPAA trained study team members will be allowed to extract 
research data from medical records and enter it into the REDCap database. At the end of the 
study, all study databases will be de-identified and archived in a locked cabinet in the Principal 
Investigator’s office. All data will be transferred and stored on encrypted devices. 
7.4
Deviations/Unanticipated Problems
A protocol deviation is any noncompliance with the protocol. The noncompliance may be either 
on the part of the participant, the investigator, or the study site staff. As a result of deviations, 
corrective actions are to be developed by the site and implemented promptly.
It is the responsibility of the site investigator to identify and report deviations within 5 calendar 
days of identification of the protocol deviation. All deviations must be addressed in study 
source documents, reported to the study sponsor, and the reviewing IRB per their policies.
Unanticipated problems (UPs) involving risks to participants or others include, in general, any 
incident, experience, or outcome that meets all of the following criteria:

Unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (b) the 
characteristics of the participant population being studied;

Related or possibly related to participation in the research ("possibly related" means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); and

Suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized.
If the study team becomes aware of an unanticipated problem (e.g. data breach, protocol 
deviation), the event will be reported to the IRB.
The UP report will include the following information:

Protocol identifying information: protocol title and number, PI's name, and the IRB 
project number;

A detailed description of the event, incident, experience, or outcome;

An explanation of the basis for determining that the event, incident, experience, or 
outcome represents an UP;

A description of any changes to the protocol or other corrective actions that have been 
taken or are proposed in response to the UP.
To satisfy the requirement for prompt reporting, UPs will be reported using the following 
timeline:

UPs will be reported to the IRB within 5 calendar days of the investigator becoming 
aware of the event.
7.5
Data Collection
Yale-New Haven Hospital (York St. Campus) will act as the coordinating center through the 
study. At each site, data will be entered on Data Collection Forms (DCFs) (Appendix 3) and 
transferred into an electronic database (REDCap) after the procedure. Each site investigator is 
responsible for complete data ascertainment at their site and entry into the electronic database. 
Each site will maintain a hard copy of completed DCFs and a key to participant code. All data 
that is collected will be de-identified. Only members of the study staff (Principal Investigator, co-
investigators, research coordinators) will have access to the electronic database.
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REDCap will be used as a central location for data processing and management. Vanderbilt 
University, with funding from the National Institutes of Health (NIH) and collaboration from a 
consortium of institutional partners, developed a software toolset and workflow methodology for 
electronic collection and management of research and clinical trial data. REDCap (Research 
Electronic Data Capture) data collection projects rely on a thorough study-specific data 
dictionary defined in an iterative self-documenting process.  REDCap was developed 
specifically around HIPAA security guidelines. REDCap has been disseminated for use locally 
at other institutions and currently supports 240+ academic/non-profit consortium partners on six 
continents and over 26,000 research end-users (https://www.project-redcap.org). REDCap 
includes safeguards to ensure complete data entry and minimizing erroneous entries. If 
needed, missing or additional information will be obtained from local site investigators.
Video recordings and scanned documents will be uploaded onto a Yale Secure Box folder that 
is only accessible to members of the study team.
7.6
Data Quality Assurance
The primary investigator will maintain records in accordance with Good Clinical Practice 
guidelines; to include:

IRB correspondence (including approval notifications) related to the clinical protocol; 
including copies of adverse event reports and annual or interim reports.

Current and past versions of the IRB-approved clinical protocol and corresponding 
IRB-approved consent form(s).

Signed Investigator’s Agreements and Certifications of Financial Interests

Master randomization list.

Copies of correspondence between primary and site investigators.
7.7
Study Records

IRB protocols (current and past versions)

IRB correspondence related to the clinical protocol

Consent forms

Data Collection Forms

Boston Bowel Preparation Score Form

Mayo Clinic Bowel Preparation Questionnaire

Adverse Event Reports

Master Randomization List

Copies of correspondence between primary and site investigators
7.8
Access to Source Documents
Source documents will be kept in a locked cabinet that resides in a locked office at each site. 
Clinical data will be warehoused in a secure, online REDCap database or in a Yale Secure 
Box folder. The Principal investigator and site investigators will be responsible for maintaining 
the records. Members of the research team will be authorized to access source documents.
7.9
Data or Specimen Storage/Security
Clinical data will be warehoused in a secure, online REDCap database or Yale Secure Box 
folder as previously described. The Principal investigator will be responsible for maintaining 
the records. Members of the research team will be authorized to access source documents. 
No specimens will be collected as part of this study.
7.10 Retention of Records
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Study documents will be retained for the duration of the study and for a minimum of 2 years 
after completion of the study. If permission is needed to move or destroy the records, the 
Principal Investigator should be contacted.
7.11 Study Monitoring
Study monitoring, including appropriate consent documentation and clinical study 
documentation, progress of the trial, assessments of data quality and timeliness, participant 
recruitment, and participant risk versus benefit will be monitored quarterly by the Principal 
Investigator. There is no increased risk to subjects due to their participation in research 
versus normal clinical practice since both treatments are already used in clinical practice.
7.12 Data Safety Monitoring Plan
Appropriate consent documentation and clinical study documentation, progress of the trial, 
including assessments of data quality and timeliness, participant recruitment, and 
participant risk versus benefit will be monitored quarterly by the Principal Investigator. 
The Principal Investigator will be responsible for monitoring the data, assuring protocol 
compliance, and conducting the safety reviews at the specified frequency, which must be 
conducted at a minimum of every 6 months (including when reapproval of the protocol is 
sought).  During the review process, the principal investigator (monitor) will evaluate whether 
the study should continue unchanged, require modification/amendment, or close to 
enrollment. Either the principal investigator or the IRB have the authority to stop or suspend 
the study or require modifications. REDCap will be used as the centralized data collection 
system, which has integrated quality control checks for collected data. These will include 
checks on completion of required data at the time of data entry. Site-specific data query will 
be available to identify missing follow-up data. A Yale Secure Box folder will be used for 
storage of video recordings and scanned documents.
Although we have assessed the proposed study as one of greater than minimal risk, the 
potential exists for anticipated and/or unanticipated adverse events, serious or otherwise, to 
occur since it is not possible to predict with certainty the absolute risk in any given individual 
or in advance of first-hand experience with the proposed study methods. Therefore, we 
provide a plan for monitoring the data and safety of the proposed study as follows:
Adverse events will be monitored for each subject participating in the study and attributed to 
the study procedures / design and graded by the Principal Investigator, Darrick Li MD, PhD, 
as described in Sections 6.2.3. All serious adverse events (as defined in Section 6.2.3) will 
be reviewed by the Principal and co-investigators to assess whether a complication was 
related to study participation. 
The Principal Investigator will report the following types of events to the IRB: 
Any incident, experience or outcome that meets ALL 3 of the following criteria:
1.
Is unexpected (in terms of nature, specificity, severity, or frequency) given (a) 
the research procedures described in the protocol-related documents, such as 
the IRB-approved protocol and informed consent document and (b) the 
characteristics of the subject population being studied; AND 
2.
Is related or possibly related to participation in the research (possibly related 
means there is a reasonable possibility that the incident, experience, or 
outcome may have been caused by the procedures involved in the research); 
AND
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3.
Suggests that the research places subjects or others at greater risk of harm 
(including physical, psychological, economic, legal, or social harm) than was 
previously known or recognized.
Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs) may be medical 
or non-medical in nature, and include – but are not limited to – serious, unexpected, and 
related adverse events and unanticipated adverse device effects.  Please note that 
adverse events are reportable to the IRB as UPIRSOs only if they meet all 3 criteria listed 
above.
These UPIRSOs will be reported to the IRB in accordance with IRB Policy 710, using the 
appropriate forms found on the website. All related events involving risk but not meeting the 
prompt reporting requirements described in IRB Policy 710 should be reported to the IRB in 
summary form at the time of continuing review. If appropriate, such summary may be a simple 
brief statement that events have occurred at the expected frequency and level of severity as 
previously documented. These reviews will assure additional independent assessment and 
evaluation of possible adverse events.
The principal investigator, Darrick Li MD, PhD, will conduct a review of all adverse events 
upon completion of every study subject. The principal investigator will evaluate the frequency 
and severity of the adverse events and determine if modifications to the protocol or consent 
form are required.
7.13 Study Modification
The Principal Investigator and the IRB have the authority to stop or suspend the study or 
require modifications. Any modifications to the study will first be submitted to the IRB for 
approval.
7.14 Study Discontinuation
If the study is prematurely terminated or suspended, the Principal Investigator will promptly 
inform study participants, the IRB, and sponsor and will provide the reason(s) for the 
termination or suspension.  Study participants will be contacted, as applicable, and be 
informed of changes to study visit schedule.
Circumstances that may warrant termination or suspension include, but are not limited to:

Determination of unexpected, significant, or unacceptable risk to participants

Demonstration of efficacy that would warrant stopping   

Insufficient compliance to protocol requirements

Data that are not sufficiently complete and/or evaluable

Determination that the primary endpoint has been met

Determination of futility
7.15 Study Completion
Study completion will occur when the number of enrolled patients meets the pre-calculated 
sample size calculation. A study closure report will be submitted to the IRB after all research 
activities have been completed.
7.16 Conflict of Interest Policy
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, is critical. Therefore, any actual conflict of interest of persons who 
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have a role in the design, conduct, analysis, publication, or any aspect of this trial will be 
disclosed and managed. Furthermore, persons who have a perceived conflict of interest will 
be required to have such conflicts managed in a way that is appropriate to their participation 
in the trial. The study leadership in conjunction with the appropriate conflict of interest review 
committee has established policies and procedures for all study group members to disclose 
all conflicts of interest and will establish a mechanism for the management of all reported 
dualities of interest.
All investigators will follow the applicable conflict of interest policies.
7.17 Funding Source
This study is not funded.
7.18 Publication Plan
The results from this study may be used by the Principal Investigator and research team for 
future publication and presentation and/or secondary parties who are conducting IRB-
approved research that request the use of de-identified data from this trial. The Principal 
Investigator holds the primary responsibility for publishing the study results.
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8 Appendices
Appendix 
#
Title
Section
Topic
1
Boston Bowel Preparation Score Form
6.2.1
Assessments 
(Efficacy)
2
Mayo Clinic Bowel Preparation Questionnaire
6.2.1
Assessments 
(Efficacy)
3
Data Collection Form
7.5
Data Collection
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9 List of Tables
Table 1. Study Schedule (Section 6.3.1)
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10 References
1.
MoviPrep: a new bowel prep for colonoscopy. Med Lett Drugs Ther, 2007. 49(1262): 
p. 47-8.
2.
Oral electrolyte solutions for colonic lavage before colonoscopy or barium enema. Med 
Lett Drugs Ther, 1985. 27(686): p. 39-40.
3.
Ell, C., et al., Randomized trial of low-volume PEG solution versus standard PEG + 
electrolytes for bowel cleansing before colonoscopy. Am J Gastroenterol, 2008. 
103(4): p. 883-93.
4.
Khan, M.A., et al., Polyethylene Glycol-3350 (Miralax(R))+1.9-L sports drink 
(Gatorade(R))+2 tablets of bisacodyl results in inferior bowel preparation for 
colonoscopy compared with Polyethylene Glycol-Ascorbic Acid (MoviPrep(R)). Turk J 
Gastroenterol, 2018. 29(1): p. 67-74.
5.
Lee, H.H., et al., Comparison Between an Oral Sulfate Solution and a 2 L of 
Polyethylene Glycol/Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy. 
J Clin Gastroenterol, 2019. 53(10): p. e431-e437.
6.
Ell, C., et al., Meta-Analysis to Assess the Influence of Two Different Schedules of 
Intake on the Efficacy, Acceptability and Safety of a New 2 Litre PEG+E Gut Cleansing 
Solution. Gastrointest Endosc, 2005. 61(5): p. PAB151.
7.
Spadaccini, M., et al., Efficacy and Tolerability of High- vs Low-Volume Split-Dose 
Bowel Cleansing Regimens for Colonoscopy: A Systematic Review and Meta-analysis. 
Clin Gastroenterol Hepatol, 2020. 18(7): p. 1454-1465 e14.
8.
Baker, F.A., et al., Predictors and colonoscopy outcomes of inadequate bowel 
cleansing: a 10-year experience in 28,725 patients. Ann Gastroenterol, 2019. 32(5): p. 
457-462.
9.
Ness, R.M., et al., Predictors of inadequate bowel preparation for colonoscopy. Am J 
Gastroenterol, 2001. 96(6): p. 1797-802.
10.
Yadlapati, R., et al., Predictors of Inadequate Inpatient Colonoscopy Preparation and 
Its Association with Hospital Length of Stay and Costs. Dig Dis Sci, 2015. 60(11): p. 
3482-90.
11.
Mahmood, S., S.M. Farooqui, and M.F. Madhoun, Predictors of inadequate bowel 
preparation for colonoscopy: a systematic review and meta-analysis. Eur J 
Gastroenterol Hepatol, 2018. 30(8): p. 819-826.
12.
Froehlich, F., et al., Impact of colonic cleansing on quality and diagnostic yield of 
colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy 
European multicenter study. Gastrointestinal endoscopy, 2005. 61(3): p. 378-384.
13.
Harewood, G.C., V.K. Sharma, and P. de Garmo, Impact of colonoscopy preparation 
quality on detection of suspected colonic neoplasia. Gastrointestinal endoscopy, 2003. 
58(1): p. 76-79.
14.
Chokshi, R.V., et al., Prevalence of missed adenomas in patients with inadequate 
bowel preparation on screening colonoscopy. Gastrointestinal endoscopy, 2012. 
75(6): p. 1197-1203.
15.
Lebwohl, B., et al., The impact of suboptimal bowel preparation on adenoma miss rates 
and the factors associated with early repeat colonoscopy. Gastrointestinal endoscopy, 
2011. 73(6): p. 1207-1214.
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16.
Murphy, D., et al., A systematic review and cost analysis of repeat colonoscopies due 
to inadequate bowel cleansing in five European countries. Expert Review of 
Pharmacoeconomics & Outcomes Research, 2019. 19(6): p. 701-709.
17.
Garber, A., et al., Modifiable Factors Associated with Quality of Bowel Preparation 
Among Hospitalized Patients Undergoing Colonoscopy. J Hosp Med, 2019. 14(5): p. 
278-283.
18.
Fuccio, L., et al., Factors That Affect Adequacy of Colon Cleansing for Colonoscopy in 
Hospitalized Patients. Clin Gastroenterol Hepatol, 2021. 19(2): p. 339-348 e7.
19.
Ergen, W.F., et al., Providing Hospitalized Patients With an Educational Booklet 
Increases the Quality of Colonoscopy Bowel Preparation. Clin Gastroenterol Hepatol, 
2016. 14(6): p. 858-864.
20.
Yadlapati, R., et al., An Automated Inpatient Split-dose Bowel Preparation System 
Improves Colonoscopy Quality and Reduces Repeat Procedures. J Clin Gastroenterol, 
2018. 52(8): p. 709-714.
21.
Argyropoulos, S.K., et al., Improving the Quality of Inpatient Bowel Preparation for 
Colonoscopies. Dig Dis Sci, 2018. 63(2): p. 338-344.
22.
Calderwood, A.H., et al., Boston Bowel Preparation Scale scores provide a 
standardized definition of adequate for describing bowel cleanliness. Gastrointest 
Endosc, 2014. 80(2): p. 269-76.
23.
Patel, M., et al., Development and validation of the Mayo Clinic Bowel Prep Tolerability 
Questionnaire. Dig Liver Dis, 2014. 46(9): p. 808-12.
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