Clinical trial NCT02802241
Conditions: Irritable Bowel Syndrome Placebo Effect Placebos Peppermint Oil
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2016-06-01; Completion date: 2019-01-01
Enrollment: 340 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: placebo intervention 2: peppermint oil
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_SAP_001.pdf: 
Study Protocol, Version 6.0 
Page 1 
 
CLINCAL STUDY PROTOCOL 
 
 
 
Efficacy of Open-label vs Double-blind Treatment in IBS. 
 
 
IND Number:  
126556 
NCT Number: 
NCT02802241 
 
Study Sponsor:  
Anthony Lembo, MD 
 
330 Brookline Avenue 
 
Boston, MA 02215 
 
Telephone: 617.667.2138 
 
Fax: 617.667.1171 
 
Date:  
June 15, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This study will be conducted according to the protocol and in compliance with Good Clinical 
Practice, the ethical principles stated in the Declaration of Helsinki, and other applicable 
regulatory requirements. 
 
 
 
 
 


Study Protocol, Version 6.0 
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TABLE OF CONTENTS 
 
 
Protocol 
Section 
Contents 
Protocol Page 
1 
Study Objectives  
3 
2 
Background and Rationale 
3 
3 
Study Design 
4 
4 
Selection and Enrollment of Participants 
5 
5 
Study Interventions 
6 
6 
Study Procedures 
7 
7 
Safety Assessments 
9 
8 
Statistical Considerations 
10 
9 
Administrative Requirements  
12 
Appendix 1 
Schedule of Study Procedures 
14 
Appendix 2 
IBS – Symptom Severity Scale 
14 
Appendix 3 
List of Evaluations to be Completed at Each Visit  
15 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Study Protocol, Version 6.0 
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1. Study Objectives 
 
1.1 Primary Objectives 
The primary objectives of this study are to: (1) to determine whether 6 weeks of open-label 
placebo, double-blind placebo and no additional treatment control results in different clinical 
outcomes in patients with IBS and (2) assuming there are significant differences (a) to 
determine whether open-label placebo results in greater clinical improvement compared to no 
additional treatment control and (b) to determine if open-label placebo results in greater clinical 
outcome than double blind placebo.   
 
1.2 Secondary Objectives 
 
To confirm our previous finding that the COMT val158met polymorphism is associated with 
placebo response.   
 
To replicate our previous finding that certain personality traits (extraversion, agreeableness, 
openness) are associated with the placebo response in IBS.   
 
Using ethnographic interviews to obtain insight into patients’ experiences, including their 
views of the clinical encounter. 
 
An exploratory objective of the study is to obtain pilot data to assess whether double-blind 
peppermint oil results in greater clinical improvement compared to double-blind placebo in 
patients with IBS. 
 
2. Background and Rationale 
 
2.1 Background on IBS 
IBS is one of the top 10 reasons for seeing a primary care physician, and the symptoms of IBS 
are present in 7-15% of the North American population. IBS is a chronic functional 
gastrointestinal disorder that is not a disease since there is no definitive pathophysiology or 
biomarker. Endpoints in clinical trials with IBS are based on subjective responses and include 
abdominal pain, altered bowel habits and bloating. The average placebo response in 
randomized double-blind placebo controlled trials in IBS is approximately 41%, making IBS a 
particularly good population to study placebo. The explanation for the high placebo response in 
clinical trials such as IBS is unclear and attempts at reducing the placebo response in clinical 
trials have been largely unsuccessful. To date no studies have compared double-blind placebo 
to open-label placebo as proposed in this study. This information is critical to understanding the 
effects of placebo as it relates to the design of clinical trials. Likewise, this information is critical 
to clinical practice, since clinical practice is unblinded yet decisions are based on inferences 
made from blinded randomized controlled trials. Including both blinded and open-label arms will 
allow us to quantify, for the first time prospectively, the difference in efficacy between these 
kinds of administrations. Such knowledge will strengthen inferences on clinical practice that are 
based on blinded randomized controlled trials.   
2.2 Study Rationale 


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The vast majority of placebos are administered with concealment (i.e., blinded assignment in 
RCTs).  Most clinicians and researchers believe that either deception or concealment is 
necessary to achieve a placebo response. To date, few studies have directly compared the 
effects of open-label placebo and double-blind placebo. We propose a novel, multi-disciplinary 
design to answer multiple clinical and research design questions concerning placebo effects.  
3. Study Design 
 
3.1 Overall Design and Plan of the Study 
This study aims to investigate the effects of open-label placebos with double-blind placebos as 
administered in a randomized controlled trial in a 6-week trial with 313 IBS patients on standard 
treatment for IBS randomly assigned to one of four arms: 
 
open-label placebo 
 
double-blind placebo 
 
double-blind peppermint oil 
 
no additional treatment control. 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2 Efficacy Assessments 
 
Primary Outcome Measure 
The primary outcome measure is the IBS symptom severity scale (IBS-SSS). The IBS-SSS is a 
questionnaire that measures the sum of the participant’s evaluation on a 100 point scale of each 
of five items: severity of abdominal pain, frequency of abdominal pain, severity of abdominal 
distension, dissatisfaction with bowel habits, and interference with quality of life. All five 
components contribute equally to the score, yielding a theoretical range of 0-500, in which a 
higher score indicates a more severe condition.  The responder will be considered a patient who 
has at least a 50 point decrease in their IBS-SSS from baseline to Visit 3. Using data from our 
previous IBS trial the calculated Cronbach's alpha is .70.  
 
Secondary Outcome Measures  
IBS-Adequate Relief: A single question: “In the last seven days, have you had adequate relief 
of your IBS symptoms?  Yes/No” 
 
IBS-Global Improvement: A single question: “Compared to the way you felt one week ago, 
have your symptoms over the past 7 days been: 1) Substantially Worse, 2) Moderately Worse, 
3) Slightly Worse, 4) No Change, 5) Slightly Improved, 6) Moderately Improved or 7) 
Substantially Improved. 
 
Randomized 
N=313 
Open-Label 
Placebo 
N≈89 
Double-Blind 
Placebo 
N≈89 
Double-Blind 
Peppermint Oil 
N≈45 
No Additional 
Treatment 
N≈89 


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SF-12 Health Survey: An assessment that measures functional health and well-being. 
 
PHQ-8: An 8-item scale that is used as a diagnostic and severity measure for depressive 
disorders in clinical studies. 
 
GAD-7: A 7-item scale that is used as a diagnostic and severity measure for anxiety disorders in 
clinical practice and research.  
 
Visceral Sensitivity Index: A measure of gastrointestinal symptom-specific anxiety. 
 
Five Factor Inventory: A 60-item instrument that measures the “Big Five” dimensions of 
personality. Cronbach alphas for the five dimensions are: N = .79, E = .79, O = .80, A = .75, C = 
.83 (Costa & McCrae 1985).  
 
Consultation and Relational Empathy Measure (CARE): Assesses physician empathy and 
relational skills on 10 ordinal items, which are then summed.  
Expectancy Question: “If I receive placebo/peppermint oil/no additional treatment, I expect my 
IBS symptoms to be: “(numerical rating scale running from zero "not improved at all" to 100 
"completely improved") 
Balanced Inventory of Desirable Reach: Describes the tendency of respondents to answer 
questions that will be viewed favorably by others.   
Pain Catastrophizing Scale: A scale that measures the tendency to magnify or exaggerate the 
seriousness of pain sensations.   
Interpersonal Support Evaluation List: Designed to measure perceptions of social support 
among individuals in the general population 
Daily Symptom Diary: Questions regarding subject symptoms will be completed daily for the 
seven day period prior to Visit 2 and Visit 3 
Miscellaneous: Additionally, details of demographics, medical history, symptoms and adverse 
events will be recorded.   
4. Selection and Enrollment of Participants 
Approximately 313 IBS patients who meet all of the inclusion criteria and none of the exclusion 
criteria will be enrolled. 
 
4.1 Inclusion Criteria 
To be eligible for enrollment, male and female patients must meet all of the following inclusion 
criteria: 
1. Provide signed and dated informed consent and understand the nature of the study 
sufficiently to allow completion of all study assessments. 
2. Be ambulatory, community dwelling, 18 to 80 years, inclusive   
3. Meet Rome IV diagnostic criteria for IBS 
4. Have IBS of at least moderate severity, i.e., have a score on the IBS-SSS of > 175 (0-
500) at the baseline visit  
5. If the patient is on medications which affect the gastrointestinal tract or visceral 
sensation (e.g., tricyclic antidepressants, fiber, antispasmodics, etc.), must be on a 


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stable dose for at least 1 month prior to entering the study and for the duration of the 
study. 
 
4.2 Exclusion Criteria 
If any of the following exclusion criteria are met, the patient is not eligible for the study: 
1. Self-reported pregnancy or planned pregnancy within the next two months. 
2. Have an established diagnosis of any concomitant bowel disturbance that would 
interfere with the assessment of efficacy or safety in the study (e.g., Hirschsprung’s 
disease, diverticulitis, colonic ischemia).  
3. Report warning symptoms (e.g., rectal bleeding, weight loss >10%, iron deficiency 
anemia, etc.) otherwise not explained 
4. Have undergone previous abdominal surgery of the intestines (with the exception of 
uncomplicated appendectomy, cholecystectomy, hysterectomy, or polypectomy > 6 
months prior to enrollment). 
5. Have a history of drug, excluding nicotine or caffeine, or alcohol abuse within 2 years of 
entry into the study  
6. Exhibit abnormalities on physical examination, unless judged to be clinically insignificant 
by the Investigator. Such cases will be noted. 
7. Current, within the past 30 days, therapeutic use of enteric coated peppermint oil for the 
treatment of IBS 
8. Known or suspected peppermint or soybean oil allergy 
9. Severe acid reflux (> 3 episodes of heartburn or regurgitation per day on average over a 
week) 
10. Inability to speak or read English  
11. Unable or unwilling to cooperate with the study protocol or considered by the 
Investigator to be unsuitable for the study. 
 
4.3 Screen Failures 
Patients will be allowed to rescreen once if they do not meet inclusion criteria #4 or #5 at the initial 
screening visit. 
 
5. Study Interventions 
 
5.1 Interventions, Administration, and Duration 
The study involves four groups as follows:  
 
open-label placebo 1 softgel TID (N~80) 
 
double-blind placebo 1 softgel TID (N~80) 
 
double-blind peppermint oil 1 softgel TID (N~40) 
 
no additional treatment control (N~80) 
 
Placebo will be supplied as soybean oil (manufactured by SoftGel Technologies Inc.), matched 
to peppermint oil softgels (Pepogest™). The open-label and double-blind placebo are identical 
and both are matched to the peppermint oil. Each peppermint oil dose is 0.2mL. Study drug 
should be administered approximately 30 minutes before meal times. 
 
5.2 Concomitant Interventions 
Patients will be allowed to continue their IBS medications (e.g., fiber, anti-spasmodics, 
loperamide, etc.) as long as they had been on stable doses for at least 30 days prior to entering 
the study and agree not to change medications or dosages during the trial. Any non-
pharmacological treatments for IBS (e.g. meditation, acupuncture, etc.) will be allowed as long 


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as they were on a stable pattern/behavior for at least 30 days prior to entering the study. All 
concomitant interventions will be recorded. Patients will be asked to refrain from making any 
major life-style changes (e.g., starting a new diet, changing their exercise pattern or starting a 
stress reduction program) during the study.  
5.3 Study Drug Accountability  
Accountability for the study drug will be the responsibility of the Research Pharmacy at Beth 
Israel Deaconess Medical Center. Drug accountability records indicating the study drug delivery 
date to the study center, inventory at the study center, and use by each subject will be 
maintained at the Research Pharmacy. These records will document that the subjects were 
provided the study drug as specified in the protocol.  
All unused study drug will be retained at the study center. 
6. Study Procedures 
The study will consist of a screening telephone call no more than 60 days prior to the screening 
visit during which subjects will be assessed for study qualification. Eligible subjects will then 
undergo three visits – screening visit (baseline assessments and randomization will occur at this 
visit); midpoint visit; and endpoint visit. 
 
6.1 Schedule of Evaluations 
 
Assessment  
 
Screening Visit  
Week 3 (± 5 
business days) 
 
Midpoint Visit 
Week 6 (± 5 
business days) 
 
Endpoint Visit 
Informed Consent Form 
X 
 
 
Clinician Interaction  
X 
X 
X 
Demographics 
X 
 
 
Medical History 
X 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
Physical Exam 
X 
X 
X 
Vital Signs 
X 
 
X 
Current Medications 
X 
 
 
Randomization 
X 
 
 
Blood for Genetic Analysis 
X 
 
X 
Questionnaires 
X 
X 
X 
Concomitant Medications 
 
X 
X 


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Adverse Events 
 
X 
X 
 
 
6.2 Description of Evaluations 
Potential participants will be screened by telephone to determine if they meet the Rome IV 
Criteria for IBS and do not suffer from other active diseases or are on medications that would 
disqualify them for enrollment.   
6.2.1 Enrollment, Baseline and Randomization 
Visit 1 (Baseline & Randomization): The informed consent will clearly indicate that the study is 
testing placebo; it will also clearly indicate that the placebo pills are inert, “like sugar pills.” 
Subjects, who provide informed consent and fulfill the inclusion and exclusion criteria, including 
an IBS-SSS of at least 175, will be eligible to enter the trial. A research coordinator will assist in 
completion of questionnaires and collection of blood. A clinician with expertise in IBS will review 
the patient’s history, perform a physical exam and confirm the diagnosis of IBS. Subjects will be 
randomly assigned to one of the four groups. Randomization will be accomplished by using 
sequentially numbered opaque sealed envelopes provided to the clinician. All assessments with 
the exception of blood collection will occur prior to randomization.  
Depending on the assignment, subjects will be given a semi-scripted discussion regarding their 
assignment. The clinician will make every effort to assure equal attention, encouragement and 
patient-clinician relationship.   
Subjects in all groups will be reminded not to make changes to their diet, exercise, and IBS 
medications, which may be continued during the study, provided that they are on a stable dose 
for 1 month. Subjects will be told to return in 3 weeks. (Note: Approximately 42 patients will be 
randomly selected to participate in the nested qualitative study and will undergo a detailed 
interview at the conclusion of Visit 3).  
 
Subjects will be instructed on the completion of the daily diary to be completed nightly for the 
seven days prior to both Visit 2 and Visit 3. 
 
6.2.2 Follow-up Visits 
 
Visits 2 and 3: At these visits, the following procedures will be performed: vital signs (Visit 3 
only), brief physical examination with clinician interaction, dispensation of pills (if appropriate), 
pill counts (if appropriate), review of concomitant medications, and documentation of adverse 
events. A research coordinator will assist in completion of questionnaires and collection of 
blood. Whenever possible, the same treatment provider will see the patient for all visits.  
 
Vital signs will not be recorded in the source documents, as they are done to mirror a standard 
clinic visit from the subject perspective and will not be analyzed. 
 
6.2.3 Sample Collection 
Genetic variation in genes encoding proteins involved in several neurotransmitter pathways has 
been shown to modify response to placebo treatment. This study will build on these findings to 
examine how placebo treatment modifies gene, protein and miRNA expression as well as 
changes in metabolism that may be associated with differential response to placebo treatment. 


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Although all these genomic studies will not be run in the primary study, it is important to collect 
samples that will allow these analyses to be done in the future. Aliquots of plasma, serum, white 
cells and red cells will be de-identified and stored at -80C.  Samples will be collected at baseline 
and at the end of the study. 
GWAS will be conducted to identify genes implicated in modifying placebo response. 
6.2.4 Blinding 
Blinding of the double-blind treatment groups will be maintained throughout the study by using 
procedures that are identical in method and appearance. The assessor who administered the 
questionnaires will be blinded to all groups. For patients randomized to either of the double blind 
administration groups, the clinician will be blinded to the treatment administered (peppermint oil 
or placebo). 
 
The Investigator and study center personnel will not have access to the randomization code 
during the study except in the case of an emergency. Breaking the blind for a subject will only 
be done in the event of a medical emergency where the identify of study drug is necessary to 
appropriately treat the subject. If the blind is broken, the reason and date will be documented. 
Every attempt will be made to maintain the blind throughout the study.  
 
6.2.5 Completion/Final Evaluation  
Efforts will be made to complete data collection on all subjects regardless of compliance with 
treatment. Those who are not compliant will be noted. 
 
There will not be any additional study procedures done for subjects that discontinue early. 
 
7. Safety Assessments 
 
7.1 Adverse Events and Serious Adverse Events 
Adverse Event: An AE is any untoward medical occurrence in a patient administered a study 
product and which does not necessarily have a causal relationship to the study product. Patients 
will be instructed to contact the Study Team at any time if any symptoms develop. 
 
Serious Adverse Event: An SAE is an event that:  
 Results in death 
 Is immediately life threatening 
 Requires inpatient hospitalization or prolongs existing hospitalization  
 Results in persistent or significant disability and/or incapacity, or 
 Is a congenital anomaly/birth defect 
 
An important medical event that may not result in death, be life threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical judgment, it 
may jeopardize the patient 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. 
 


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At every study visit, patients will be asked questions to elicit medically related changes in their well-
being. They will also be asked if they have been hospitalized, had any accidents, used any new 
medications, or changed concomitant medication regimens. Any difference in responses to any 
question on the side effects questionnaire between visits will not be considered an adverse event 
unless the subject verbally informs the research team.  
 
7.2 Reporting Procedures 
All AEs observed from the time the patient receives the first treatment until the last follow-up visit 
will be recorded on the CRF. The description of the AE will include the type of event, onset date, 
assessment of severity, date of resolution of event, seriousness, any required treatment of 
evaluations, and outcome. 
 
All SAEs will be reported to the Beth Israel Deaconess Medical Center Institutional Review Board 
(IRB). In addition, the FDA will be notified of all serious and unexpected AEs in an IND safety 
report no later than 15 calendar days after awareness of the event and 7 days after a suspected 
unexpected serious adverse event that results in death.  
 
A formal report from the DSMB will be supplied to NCCIH, which will be communicated to the PI 
and the Beth Israel Deaconess Medical Center. Each report will conclude with a 
recommendation to either 1) continue the study without changes; 2) continue the study with 
changes; or 3) terminate the study. This recommendation will be made by formal majority vote 
and fully justified by the preceding report. 
 
Any AEs observed that are unanticipated will be reported under the following schedule: 
1. 
Unanticipated problems that are serious adverse events will be reported to the IRB 
within 1 week of the investigator becoming aware of the event. 
2. 
Any other unanticipated problem will be reported to the IRB within 2 weeks of the 
investigator becoming aware of the problem. 
8. Statistical Considerations 
8.1 Randomization 
Treatment assignments will be generated using permuted block randomization with randomly 
varying block sizes. Randomization will be done in a 2:2:2:1: ratio (open-label placebo; double-
blind placebo; no treatment control; double blind peppermint oil). Randomization for the 
qualitative sub-study will be done. Randomized assignments to one of the four groups will be 
sealed in sequentially numbered opaque envelopes. 
A random subset of approximately 57 of the participants will be selected for participation in the 
nested qualitative study. The participants will be randomly selected in the same ratio as the 
primary randomization. Care providers will be blinded to participation in the sub study. A list of 
selected randomization IDs and access to the REDCap patient scheduling module will be 
provided to the interviewer so that he or she can conduct the qualitative interview after the 
participant has completed the final clinical evaluation. 
8.2 Stratification  


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Stratification will be based on IBS symptom severity score (< 300 and > 300) and gender, 
resulting in 4 strata. Each stratum will have a different color randomization envelope and a 
unique set of randomization ID numbers. 
8.3 Analyses 
All tests will be two-tailed with =.05. For our primary analyses, we will use a modified intention-
to-treat analysis including any patient who was randomized and provided a baseline 
assessment and at least one post-baseline primary outcome assessment. We will also run per 
protocol analyses, and any substantive differences between the two methods will be reported. 
We will examine the amount of missing data and the nature of the missingness (missing 
completely at random, missing at random, and missing not a random). If necessary, we will 
conduct a full intention to treat analysis.  
Aim 1. To determine whether 6 weeks of open-label placebo, double-blind placebo and no-
treatment results in different clinical outcomes.  To test this aim, we will conduct a one-way 
analysis of covariance. In addition to treatment group, the model will include baseline IBS-SSS 
and stratification factors for gender and symptom severity. 
Assuming that there is a significant difference between the 3 groups, Dunnett’s analysis will be 
used to do pairwise analyses of the following aims 
1a. To determine if 6 weeks of open-label placebo results in superior clinical outcome than no 
treatment control.  Hypothesis: open-label placebo > no treatment control. 
1b. To determine if 6 weeks of open-label placebo results in superior clinical outcome than 
double blind placebo.  Hypothesis: open-label placebo > double-blind placebo. 
Secondary Aims Analysis Plan:  There are three secondary multi-disciplinary aims in this 
study.   
Secondary Aim 1 (Genetics Aim): In our previous large RCT we found that the number 
methionine alleles in COMT val158met was associated with placebo responses especially to a 
combined placebo and supportive patient-provider relationship. We plan to confirm these 
findings and extend them by evaluating additional candidate genes implicated in placebo.   
Exploratory analyses will be performed in other candidate genes associated with placebo 
including: the mu-opioid receptor polymorphism (OPRM1 A118G), FAAH polymorphisms 
Pro129Thr. monoamine oxidase gene polymorphisms, and serotonin-related polymorphism 
CGTTLPR and G-703T (polymorphism in the tryptophan hydroxylase-2 (TPH-2) gene 
promoter).  
DNA will be extracted from those study participants who agree to the genetic screening and will 
be analyzed by a TaqMan allele discrimination assay. Subsequently, COMT and other 
candidate genotypes will be correlated with response to placebo or active drug treatment using 
the above mentioned outcomes. Furthermore, potential correlations of the COMT and other 
genotypes and patient-disease characteristics, for instance pain experience at baseline, will be 
examined.   
Secondary Aim 2 (Psychological Aim): In our previous large RCT in IBS we found that higher 
levels of extraversion, agreeableness, and openness to experience are associated with 
increased response to placebo treatment, especially with an augmented patient-practitioner 
relationship.  We will use the Five Factor Inventory (FFI) to measure these personality traits and 


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then use multiple regression to examine their association with outcomes after controlling for 
baseline severity.    
Secondary (exploratory) Aim: To determine if 6 weeks of double-blind peppermint oil results in 
greater improvement than double-blind placebo in patients with IBS.  Hypothesis:  Double-blind 
peppermint oil > Double-blind placebo. To test this aim, we will conduct an analysis of 
covariance. In addition to treatment group, the model will include baseline IBS-SSS and 
stratification factors for gender and symptom severity. 
8.4 Power Calculations: To estimate the effect size for Aim 1, we used our previous pilot trial in 
IBS.  In that study, the effect size for the difference between open-label placebo and no-
treatment on the IBS Symptom Severity Scale was d=0.53.  For this comparison, there will be 
88 patients in each group, and using ANCOVA to control for baseline scores leaves the power 
for the 3 group comparison at .96.  To estimate the power for secondary (exploratory) aim using 
ANCOVA to control baseline scores leaves the power of .60;  however, using more recent data 
that suggest an effect size of d=0.50, the power would be .78. 
8.5 Missing Data Minimization Strategies: Missing data minimization strategies includes 
patient retention efforts and a modified intent-to-treat analysis. Each individual patient reported 
assessment will be captured electronically at each visit with missing responses prohibited by the 
electronic system.   
9. Administrative Requirements 
 
9.1 Good Clinical Practice 
The study will be conducted in accordance with the International Conference on Harmonization 
(ICH) for Good Clinical Practice (GCP). Essential clinical documents will be maintained to 
demonstrate the validity of the study and the integrity of the data collected. Files will be 
established at the beginning of the study, maintained for the duration of the study, and retained 
according to appropriate regulations. 
 
9.2 Data Management 
Data will be recorded and stored via REDCap. Data will be recorded on REDCap as the study is 
in progress. All passwords will be strictly confidential. 
 
9.3 Protocol Deviations/Violations 
If a subject does not complete a daily diary entry, it will not be considered a protocol 
deviation/violation. If blood is not obtained at either Visit 1 or Visit 3, it will not be considered a 
protocol deviation/violation. 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix 1 
 
Schedule of Study Procedures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix 2 
 
IBS-Severity Scoring System 
Instructions 
These questions are designed to enable us to record and monitor the severity of your IBS. It is 
to be expected that your symptoms might vary over time, so please try and answer the 
questions based on how you currently feel (i.e. over the last 10 days or so). All information will 
be kept in strict confidence. 
 
1. For questions where a number of different responses are a possibility please circle the 
response appropriate to you. 
2.  Some questions will require you to write in an appropriate response. 
3.  Some questions require you to put a cross on a line which enables us to judge the severity of 
a particular problem. 
 
Please place your cross (X) anywhere on the line between 0-100% in order to indicate as 
indicate as accurately as possible the severity of your symptom. 
 
This example shows a severity of approximately 90%. 
 
              0%|-------------------------------------------------------------------------------------X-----| 100% 
            no pain 
 
   not very 
         quite  
            severe  
     very  
 
   or discomfort          severe 
        severe 
 
 
  
    severe 
 
1.    Do you currently suffer from abdominal pain?     Yes  No 
1b. If yes, how severe is your abdominal pain?  Please make an “X” anywhere on the line. 
 
              0%|-------------------------------------------------------------------------------------------| 100% 
            no pain 
 
   not very 
         quite  
            severe  
     very  
 
   or discomfort          severe 
        severe 
 
 
  
    severe 
 
1c. Out of 10 days, how many days do you experience abdominal pain?   _______ 
2.  Do you currently suffer from abdominal distention (bloating, swelling, or tightness)?  
   Yes 
 No 
2b. If yes, how severe is your abdominal distention?  Please make an “X” anywhere on the line. 
 


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              0%|-------------------------------------------------------------------------------------------| 100% 
            no distention    not very 
         quite  
            severe  
     very  
                                    
severe 
        severe 
 
 
  
    severe 
 
 
              
 
 
very happy                    quite happy                     unhappy                           very unhappy 
 
 
4.   How much does your IBS affect or interfere with your life in general?  Please make an “X” 
anywhere on the line. 
              0%|-------------------------------------------------------------------------------------------| 100% 
 
not at all                           not much                        quite a lot                          completely 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.  How satisfied are you with your bowel habit?  Please make an “X” anywhere on the line. 
             0%|-------------------------------------------------------------------------------------------| 100% 


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Appendix 3 
 
List of Evaluations to be Completed at Each Visit  
 
Paper Source Documents 
 
Evaluation 
Visit 1 Visit 2 Visit 3 
Telephone screening 
 
 
 
Original signed ICF 
X 
 
 
Physical Examination 
X 
X 
X 
Rome IV Diagnostic Criteria 
X 
 
 
IBS-SSS 
X 
X 
X 
Visit 1 Template 
X 
 
 
Visit 2 Template 
 
X 
 
Visit 3 Template 
 
 
X 
Concomitant Medication Log 
X 
X 
X 
Adverse Event Log 
 
X 
X 
Blood Collection 
X 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Entered Directly into RedCap 
 
Evaluation 
Visit 1 Visit 2 Visit 3 
Rome IV Module 
X 
 
 
Symptom Questionnaire  
 
X 
X 
Why are you participating? 
X 
 
 
IBS-ARS 
X 
X 
X 
IBS-GIS 
X 
X 
X 
Blinding Question 
 
X 
X 
Expectancy Question  
X 
 
 
Medication Adherence Questionnaire 
 
X 
X 
Side Effects Questionnaire 
X 
 
X 
PHQ-8 
X 
 
 
GAD-7 
X 
 
 
VSI 
X 
 
X 
SF-12 
X 
 
 
FFI 
X 
 
 
CARE 
 
 
X 
PCS 
X 
 
X 
BIDR 
 
 
X 
ISEL-12 
X 
 
X 
Daily Questionnaire 
 
 
 
* All questionnaires above are completed by the subjects. The demographic and Visit 1 IBS-
SSS data in RedCap is completed by stuff staff. 

ICF_000.pdf: 
[CCI] Committee on Clinical Investigations 
 
Page 1 of 11 
Informed Consent – Part D 
CCI Form: 3-2013 
PI Revision Date: 8/6/2018  
 
 
 
INFORMED CONSENT FORM TO TAKE PART IN A RESEARCH STUDY 
 
 
SUBJECT’S NAME:        
TITLE OF RESEARCH PROTOCOL:  Efficacy of Open-label vs Double-blind Treatment in IBS 
PRINCIPAL INVESTIGATOR:  Anthony Lembo, MD 
PROTOCOL NUMBER:  2015P000282 
 
INTRODUCTION: 
 This is a research study; 
 Your participation is voluntary; 
 A research study includes only people who choose to take part; 
 You may or may not benefit from participating in the study.  However, your participation 
may help others in the future as a result of knowledge gained from the research; 
 You may leave the study at any time; 
 If you choose not to take part, or if you leave the study, your decision will in no way harm 
your relationship with any member of the research team or any other individuals at Beth 
Israel Deaconess Medical Center. 
 
Please read this consent form carefully and ask the investigators or study staff to explain any words or 
information that you do not clearly understand.  Once you read this consent form and understand what 
your participation in this study will involve, you will be asked to sign this form if you wish to take part.  
You will be given a signed copy of the form to keep for your records. 
 
DISCLOSURE OF SPECIAL INTERESTS OF BIDMC AND INVESTIGATORS 
This study is being conducted by Dr. Anthony Lembo.  It is being funded by the National Institute of 
Health (NIH).  Neither BIDMC nor Dr. Lembo have any additional interests in this research project. 
 
WHOM TO CONTACT IF YOU HAVE QUESTIONS OR PROBLEMS 
If you have any questions, concerns or complaints about this research or experience any problems, 
you should contact Anthony Lembo, MD at [617] 667-2138.  
 
PURPOSE 
Irritable bowel syndrome (IBS) is a gastrointestinal disorder characterized by chronic abdominal pain 
or discomfort and altered bowel function (i.e., constipation, diarrhea, or alternating constipation and 
**FOR CCI USE ONLY** 
Approved by the Beth Israel Deaconess Medical Center Committee on 
Clinical Investigations:  
 
Consent Approval Date:   
08/17/2018 
 
 
 
Protocol Number:  
2015P000282 
 
   
 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
06/23/2020


  [CCI] Committee on Clinical Investigations 
Page 2 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: EFFICACY OF OPEN-LABEL VS DOUBLE-
BLIND TREATMENT IN IBS 
PRINCIPAL INVESTIGATOR'S NAME: ANTHONY LEMBO, MD 
PROTOCOL #: 2015P000282 
 
Informed Consent – Part D 
CCI Form: 3-2013 
PI Revision Date:  8/6/2018  
 
 
diarrhea).  
 
Evidence exists that indicates that placebos and peppermint oil can have beneficial effects in 
patients with IBS. In addition, in a previous study, it was shown that patients can be successfully 
treated for IBS with both open-label and blinded placebo. Blinded means that patients do not know 
which medication they are receiving. A placebo is a pill that looks like the peppermint oil pills, but 
contains no active material.   
 
The main purpose of this study is to harness the placebo effect and study the effects of peppermint oil 
in IBS. 
 
STUDY PARTICIPANTS 
You have been asked to be in the study because you have irritable bowel syndrome.  
 
Approximately 400 people will take part in this study at Beth Israel Deaconess Medical Center.   
 
DESCRIPTION OF STUDY DETAILS 
If you agree to be in this study, you will be asked to read and sign this consent form.  After you sign the 
consent form, the following things will happen: 
 
Visit 1:   
Screening procedures are tests and procedures that will be done to determine if you are eligible to 
take part in the research study.  For this research study, the screening procedures include a medical 
history review and physical exam.  
 
If you are eligible for participation after the medical history review and physical exam including vital 
signs, you will be randomly assigned (like the flip of a coin) to receive either 1) placebo delivered 
openly (open-label) or 2) placebo or peppermint oil delivered double-blind or 3) continuation with 
your previous treatment with no additions. Both placebo and peppermint oil will be taken three times 
daily before meals for six weeks. 
 
You will not be able to choose the study group to which you will be assigned. 
 
Open-label means that both you and the study clinician will know whether you are receiving placebo 
or peppermint oil.  Double-blind means that neither you nor the study clinician will know whether you 
will be receiving the placebo or peppermint oil. However, this information can be learned in case of 
an emergency. 
 
After you receive your group assignment, the following procedures will occur: 
 Completion of questionnaires related to your gastrointestinal symptoms, overall health and 
well-being, and personal characteristics 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
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  [CCI] Committee on Clinical Investigations 
Page 3 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: EFFICACY OF OPEN-LABEL VS DOUBLE-
BLIND TREATMENT IN IBS 
PRINCIPAL INVESTIGATOR'S NAME: ANTHONY LEMBO, MD 
PROTOCOL #: 2015P000282 
 
Informed Consent – Part D 
CCI Form: 3-2013 
PI Revision Date:  8/6/2018  
 
 
 Dispensation of study treatment  
 Collection of blood for genetic analysis.  
 You will also be asked to keep a daily symptom diary for the seven days prior to Visit 2 and 
the seven days prior to Visit 3 
 
Visit 2: 
Visit 2 will occur three weeks after Visit 1.  At Visit 2, the following procedures will occur: 
 Completion of questionnaires related to your gastrointestinal symptoms, overall health and 
well-being, and personal characteristics 
 Physical exam 
 Updates on medical history 
 Dispensation of study treatment  
 
Visit 3: 
Visit 3 will occur three weeks after Visit 2.  At Visit 3, the following procedures will occur: 
 Completion of questionnaires related to your gastrointestinal symptoms, overall health and 
well-being, and personal characteristics 
 Vital signs 
 Physical exam 
 Updates on medical history 
 Collection of blood for genetic analysis.  
 
In addition, between Visit 1 and Visit 2 and also Visit 2 and Visit 3, there will be a brief contact to 
check-in on the status of the study. 
 
Approximately 57 patients will be randomly asked to participate in an open-ended interview that will 
be focused on why patients chose to participate and their thoughts about placebo and the study 
overall.  This would occur at Visit 3 and will last for approximately 30 minutes.  If you are asked to 
participate in the interview, it would be audio-recorded to allow for transcription. 
 
 
I agree to allow my interview to be audio-recorded.     
 Yes   
 No      
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Subject  
 
 
 
 
Date 
  
 
 
 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
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  [CCI] Committee on Clinical Investigations 
Page 4 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: EFFICACY OF OPEN-LABEL VS DOUBLE-
BLIND TREATMENT IN IBS 
PRINCIPAL INVESTIGATOR'S NAME: ANTHONY LEMBO, MD 
PROTOCOL #: 2015P000282 
 
Informed Consent – Part D 
CCI Form: 3-2013 
PI Revision Date:  8/6/2018  
 
 
 
Future Use of Blood 
Any blood from Visit 1 or Visit 3 that is remaining after the genetic analysis will be saved and stored 
frozen at BIDMC. There is no limit on the length of time your blood will be kept. The stored blood will 
not contain any identifiable information, but will contain your research study subject code.  We may 
keep all remaining blood for research indefinitely unless you decide to withdraw your samples by 
contacting the PI (Anthony Lembo, MD at 617.667.2138). The samples may be used for future 
analysis related to IBS as more information becomes available. This analysis could include 
analyzing proteins, DNA, RNA or other genetic biomarkers that are part of future scientific discovery. 
It is possible that this may be part of a separate unrelated study. The samples may be used by the 
study team and their collaborators. If the samples are used by collaborators, your samples will be 
sent with your research study subject code, but not any identifiable information. Collaborators will 
not have access to the link between your code number or any of your protected health information  
You will not be informed of any future findings and there is no additional risk to you associated with 
storing the samples. De-identified information related to your diagnosis, treatment and study results 
will also be saved. However, it is not known how or if this information will be used in the future. 
 
 
I agree to allow storing information and the remaining blood for future analysis.     
 Yes   
 No      
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Subject  
 
 
 
 
Date 
 
 
 
RISKS AND DISCOMFORTS 
As a result of your participation in this study, you are at risk for side effects listed in this section.  
You should discuss these with the investigator and with your regular doctor if you choose. 
 
Blood Drawing 
The risks and discomforts of blood drawing from a vein include the possibility of pain or bruising at 
the site of the blood draw; occasional feeling of lightheadedness; and rarely, infection at the site of 
the blood draw. 
 
RISKS ASSOCIATED WITH SURVEYS/QUESTIONNAIRES 
Some of the questions we will ask as part of this study may make you feel uncomfortable.  You may 
refuse to answer any of the questions and you may take a break at any time during the study.  You 
may stop your participation in the study at any time. 
 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
06/23/2020


  [CCI] Committee on Clinical Investigations 
Page 5 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: EFFICACY OF OPEN-LABEL VS DOUBLE-
BLIND TREATMENT IN IBS 
PRINCIPAL INVESTIGATOR'S NAME: ANTHONY LEMBO, MD 
PROTOCOL #: 2015P000282 
 
Informed Consent – Part D 
CCI Form: 3-2013 
PI Revision Date:  8/6/2018  
 
 
LOSS OF CONFIDENTIALITY 
There is the potential for loss of confidentiality by participating in this study.  Every effort will be 
made to protect the confidentiality of your identifiable information.   
 
This research involves the possible identification of genetic information about you (and individuals 
genetically related to you. Additional information about this gene and your present or future health 
may be discovered at a rapid pace. 
 
You will not have the option of being advised of the results of the research that relate to your 
biological samples. 
 
CERTIFICATE OF CONFIDENTIALITY 
A Certificate of Confidentiality has been obtained from the Department of Health and Human 
Services.  This will help further protect information that may identify you.  The Certificate prevents 
the investigator from being forced to disclose information that may identify you for use in court.   
 
A Certificate of Confidentiality does not prevent you or anyone you tell from voluntarily releasing 
information about yourself or your involvement in this research.  The investigator may not withhold 
information if you give your health insurance company or employer permission to receive information 
about your participation in this research.  This means that you and your family must also actively 
protect your own privacy. 
 
Finally, the investigator can take steps, including reporting to authorities as required by law, to 
prevent serious harm to yourself or others. 
 
There is a possibility that information that identifies you will be given to the Beth Israel Deaconess 
Medical Center oversight officials or to officials of the Department of Health and Human Services.  
This Information may be used for audits or evaluations, or to ensure that research work is being 
done correctly.  However, these officials are also obliged to protect your privacy. 
 
CONFIDENTIALITY 
Information learned from your participation in this study and from your medical record may be 
reviewed and photocopied by the Food and Drug Administration (FDA) and/or other federal and 
state regulatory agencies, accreditation agencies, the Committee on Clinical Investigations, the 
Human Subjects Protection Office and others involved in research administration of the Beth Israel 
Deaconess Medical Center with protection of confidentiality so far as permitted by applicable law.  
Information resulting from this study and from your medical record may be used for research 
purposes and may be published; however, you will not be identified by name in such publications. 
 
A copy of this consent form and information collected during this research may become part of your 
medical record, if the information is relevant to the care you receive at Beth Israel Deaconess 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
06/23/2020


  [CCI] Committee on Clinical Investigations 
Page 6 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: EFFICACY OF OPEN-LABEL VS DOUBLE-
BLIND TREATMENT IN IBS 
PRINCIPAL INVESTIGATOR'S NAME: ANTHONY LEMBO, MD 
PROTOCOL #: 2015P000282 
 
Informed Consent – Part D 
CCI Form: 3-2013 
PI Revision Date:  8/6/2018  
 
 
Medical Center. Medical records are considered permanent records; therefore, information cannot 
be deleted from the record. Medical records are available to health care professionals at Beth Israel 
Deaconess Medical Center and may be reviewed by staff when carrying out their responsibilities, as 
well as by external parties such as health care insurers and others in certain circumstances. If you 
are not currently a patient at Beth Israel Deaconess Medical Center and do not have a medical 
record at Beth Israel Deaconess Medical Center, one may be created for you for your participation in 
this research. You may also be required to register as a patient of Beth Israel Deaconess Medical 
Center in order to participate in this research.  
 
POSSIBLE BENEFITS 
It is not possible to predict whether you will benefit directly from participation in this study.  However, 
your participation may help others in the future as a result of knowledge gained from the research. 
 
OTHER AVAILABLE OPTIONS 
Taking part in this study is voluntary.  Instead of being in this study, you have the following options: 
 There are commonly used treatments available for persons who have IBS including 
FDA-approved medications to treat pain, spasms and change in bowel habits.  Anti-
depressants and antibiotics may also help.  
 Nutritional interventions may also be helpful 
 To not take part in the study. 
 
This research study is not meant to diagnose or treat medical problems. Participation in this 
research study does not take the place of routine physical examinations or visits to your regular 
doctor. 
 
We recommend that you discuss these and other options with the investigator and your regular 
doctor so that you can make a well-informed decision about participating in this study. 
 
IF YOU DECIDE NOT TO TAKE PART IN THE STUDY 
Participation in this study is voluntary.  You have the right to decide not to take part in this study.  If 
you choose to participate, you have the right to leave the study at any time. Your decision to not 
participate will not result in any penalties or loss of benefits to you. The investigators will tell you 
about new information that may affect your willingness to stay in this study.  
 
If you decide not to participate in the study or decide to leave the study early, your decision will not 
affect your relationship with the research team or any other individual at Beth Israel Deaconess 
Medical Center.   
 
INVESTIGATORS RIGHT TO STOP THE STUDY 
The investigators have the right to end your participation in this study if they determine that you no 
longer qualify to take part, or if it would be dangerous for you to continue, or if you do not follow 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
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  [CCI] Committee on Clinical Investigations 
Page 7 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: EFFICACY OF OPEN-LABEL VS DOUBLE-
BLIND TREATMENT IN IBS 
PRINCIPAL INVESTIGATOR'S NAME: ANTHONY LEMBO, MD 
PROTOCOL #: 2015P000282 
 
Informed Consent – Part D 
CCI Form: 3-2013 
PI Revision Date:  8/6/2018  
 
 
study procedures as directed by the investigators.  Beth Israel Deaconess Medical Center or the 
funding source may stop the study at any time. 
 
COSTS AND/OR PAYMENTS TO YOU 
 
COSTS COVERED BY STUDY 
You will not be charged for any of the medications, tests or procedures that are a part of this 
research study.  
 
COST OF RESEARCH RELATED INJURY: 
If you are injured as a direct result of your participation in this study you should contact the 
Investigator at the number provided under the section “Whom to Call if You Have Questions” in this 
form.  You will be offered the necessary care to treat your injury.  You or your insurance company 
will be billed for medical care and/or hospitalization related to this injury.  You will be responsible for 
all co-payments and deductibles required under your insurance.  BIDMC will consider 
reimbursement of injury related expenses not covered by your insurance on a case-by-case basis.  
At this time there is no plan to reimburse you for items such as lost wages or lost time from work.  
By signing this consent form you have not given up any legal rights. 
 
PAYMENTS TO YOU: 
You will receive a parking voucher or single-use MBTA ticket for each visit. If your scheduled visit 
occurs outside of MBTA operating hours or if a disability affects your ability to use fixed MBTA 
routes, transportation costs will be reimbursed with a receipt if within the city of Boston.     
 
OTHER IMPORTANT INFORMATION  
A description of this clinical trial will be available on www.ClinicalTrials.gov as required by U.S. law.  
This Web site will not include information that can identify you.  At most, the Web site will include a 
summary of the results.  You can search this Web site at any time. 
 
AUTHORIZATION FOR USE AND DISCLOSURE OF YOUR PROTECTED HEALTH 
INFORMATION 
As part of this study, we will be collecting, using and sharing with others information about you.  
Please review this section carefully as it contains information about the federal privacy rules and the 
use and disclosure of your information.   
 
PROTECTED HEALTH INFORMATION [PHI] 
By signing this informed consent document, you are allowing the investigators and other authorized 
personnel to use [internally at BIDMC] and disclose [to people and organizations outside the BIDMC 
workforce identified in this consent] health information about you.  This may include information 
about you that already exists (for example: your medical records and other sources of health 
information, demographic information, the results of any laboratory tests, and mental health records 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
06/23/2020


  [CCI] Committee on Clinical Investigations 
Page 8 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: EFFICACY OF OPEN-LABEL VS DOUBLE-
BLIND TREATMENT IN IBS 
PRINCIPAL INVESTIGATOR'S NAME: ANTHONY LEMBO, MD 
PROTOCOL #: 2015P000282 
 
Informed Consent – Part D 
CCI Form: 3-2013 
PI Revision Date:  8/6/2018  
 
 
if applicable as well as any new information generated as part of this study.  This is your Protected 
Health Information. 
 
PEOPLE/GROUPS AT BIDMC WHO WILL SHARE AND USE YOUR PROTECTED HEALTH INFORMATION 
Your Protected Health Information may be shared with and used by investigators listed on this 
consent form as well as the supporting research team [i.e. research assistants and coordinators, 
statisticians, data managers, laboratory personnel, pharmacy personnel, administrative assistants], 
and may also be shared and used by other health care providers at BIDMC who have treated you in 
the past and have information relevant to the research, or who provide services to you in connection 
with the research.  Your Protected Health Information may also be shared with the members and 
staff of the Committee on Clinical Investigations of Beth Israel Deaconess Medical Center, which is 
responsible for reviewing studies for the protection of the research subjects.  
 
PEOPLE/GROUPS OUTSIDE OF BIDMC WITH WHOM YOUR PROTECTED HEALTH INFORMATION WILL BE 
SHARED 
We will take care to maintain confidentiality and privacy about you and your Protected Health 
Information.  We may share your Protected Health Information with the following groups so that they 
may carry out their duties related to this study: 
 
 Laboratories not affiliated with BIDMC that are involved in conducting tests related to the 
research 
 Statisticians and other data monitors not affiliated with BIDMC 
 Centralized data collectors  
 Your health insurance company 
 The Food and Drug Administration [FDA], the Department of Health and Human Services 
[DHHS], the National Institute of Health [NIH], the Office for Human Research Protections 
[OHRP], and other federal and state agencies that may have jurisdiction over the research 
 Hospital and Clinical Research Accrediting Agencies 
 Data and Safety Monitoring boards that oversee this study (if applicable) 
 
Those who receive your Protected Health Information during the course of the research may not be 
required by the federal privacy regulations to protect it, and they may make further disclosures to 
others and use your information without being subject to penalties under those laws.   
 
WHY WE ARE USING AND SHARING YOUR PROTECTED HEALTH INFORMATION 
The main reason for using and sharing your Protected Health Information is to conduct and oversee 
the research as described in this Informed Consent Document.  There are many other reasons 
beyond the research for which BIDMC may use or disclose your Protected Health Information.  Not 
all of these reasons require your express written authorization.  For example, we will use and share 
your Protected Health Information to ensure that the research meets legal, institutional and 
accreditation requirements and to conduct public health activities.  The various ways in which 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
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  [CCI] Committee on Clinical Investigations 
Page 9 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: EFFICACY OF OPEN-LABEL VS DOUBLE-
BLIND TREATMENT IN IBS 
PRINCIPAL INVESTIGATOR'S NAME: ANTHONY LEMBO, MD 
PROTOCOL #: 2015P000282 
 
Informed Consent – Part D 
CCI Form: 3-2013 
PI Revision Date:  8/6/2018  
 
 
BIDMC may use and disclose your protected health information without your authorization are 
explained in a document called the Notice of Privacy Practices.  If you have not received a copy of 
BIDMC’s Notice of Privacy Practices, please ask us for one and review it before signing this form.  In 
addition to signing this document, you may also be asked to sign a BIDMC General Agreement form 
acknowledging that you have received the BIDMC Notice of Privacy Practices.   
 
NO EXPIRATION DATE – RIGHT TO WITHDRAW AUTHORIZATION 
Your authorization for the use and disclosure of your Protected Health Information in this Study shall 
never expire.  However, you may withdraw your authorization for the use and disclosure of your 
Protected Health Information at any time provided you notify the Principal Investigator in writing.  If 
you would like to take back your authorization so that your Protected Health Information can no 
longer be used in this study, please send a letter notifying the Principal Investigator of your 
withdrawal of your authorization to Anthony Lembo, at 330 Brookline Ave., Boston, MA. Please be 
aware that the investigators in this study will not be required to destroy or retrieve any of your 
Protected Health Information that has already been used or disclosed before the Principal 
Investigator receives your letter, and they are permitted to continue to use and disclose your 
previously collected information as necessary to complete the research. 
 
REFUSAL TO SIGN 
Your clinical treatment may not be conditioned upon whether you sign the Authorization for 
Research. However, if you choose not to sign this informed consent document and authorization for 
the use and disclosure of your Protected Health Information, you will not be allowed to take part in 
the research study. 
 
RIGHT TO ACCESS AND COPY YOUR PHI 
If you wish to review or copy your Protected Health Information as it is made part of your medical 
record, you may do so after the completion or termination of the study by sending a letter to the 
Principal Investigator requesting a copy of your Protected Health Information.  You may not be 
allowed to inspect or copy your Protected Health Information until this study is completed or 
terminated. 
 
ADDITIONAL CONTACT FOR QUESTIONS OR CONCERNS 
You may contact the Human Subjects Protection Office at [617] 975-8500 in the event that you 
would like to obtain information or to offer input about the research study.   This office is 
independent of the investigator or investigator’s research staff and can also assist with questions 
relating to your rights as a participant in research, which may include questions, concerns or 
complaints about your participation in the study. 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
06/23/2020


  [CCI] Committee on Clinical Investigations 
Page 10 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: EFFICACY OF OPEN-LABEL VS DOUBLE-
BLIND TREATMENT IN IBS 
PRINCIPAL INVESTIGATOR'S NAME: ANTHONY LEMBO, MD 
PROTOCOL #: 2015P000282 
 
Informed Consent – Part D 
CCI Form: 3-2013 
PI Revision Date:  8/6/2018  
 
 
THE FOLLOWING PARAGRAPHS CONTAIN SOME STANDARD INFORMATION WHICH 
GENERALLY APPLIES TO INDIVIDUALS PARTICIPATING IN A RESEARCH STUDY. 
 
CONSENT FORM FOR CLINICAL RESEARCH 
I have read the previous page[s] of the consent form and the investigator has explained the details of the 
study.  I understand that I am free to ask additional questions. 
 
If I wish additional information regarding this research and my rights as a research subject, or if I believe I 
have been harmed by this study, I may contact the Human Subjects Protection Office (HSPO). 
 
I am aware that this is a research project and that unforeseen side effects may occur. 
 
I understand that the Beth Israel Deaconess Medical Center has no formal program for compensating 
patients for medical injuries arising from this research.  Medical treatment will be provided for injuries at the 
usual charge to me or to my insurer unless payment is otherwise provided for in this consent form. 
 
I understand that participation in this study is voluntary and I may refuse to participate or may discontinue 
participation at any time without penalty, loss of benefits, or prejudice to the quality of care which I will 
receive. 
 
I acknowledge that no guarantees have been made to me regarding the results of the treatment involved in 
this study, and I consent to participate in the study and have been given a copy of this form. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Subject or 
 
 
 
 
Date 
Legally Authorized Representative   
(Parent if the subject is a minor) 
 
 
 
 
 
 
 
 
 
 
 
Relationship of Legally Authorized Representative to Subject   
 
The subject has been given the opportunity to read this consent form and to ask questions before signing, and 
has been given a copy. 
 
 
___________________________________________________________ 
SIGNATURE OF INVESTIGATOR/Co-Investigator   
DATE 
 
__________________________________________________________ 
PRINT INVESTIGATOR’S/Co-Investigator’s  
NAME 
 
 
A signing co-investigator must be listed on the study’s approved Research Staffing Form at the time of consent. 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
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  [CCI] Committee on Clinical Investigations 
Page 11 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: EFFICACY OF OPEN-LABEL VS DOUBLE-
BLIND TREATMENT IN IBS 
PRINCIPAL INVESTIGATOR'S NAME: ANTHONY LEMBO, MD 
PROTOCOL #: 2015P000282 
 
Informed Consent – Part D 
CCI Form: 3-2013 
PI Revision Date:  8/6/2018  
 
 
 
THE FOLLOWING SECTIONS ARE NOT NEEDED FOR ALL STUDIES AND SHOULD BE 
UTILIZED AS INDICATED: 
 
If the subject is able to speak and understand English but is not able to read or write  
 
I was present during the entire oral presentation of the informed consent and witnessed the subject’s agreement to 
participate in the study. 
 
Signature of Witness:  
 
Printed Name of Witness:  
 
Date:   
 
 
If the subject is able to understand English but is not physically able to read or write or see 
 
I was present during the entire oral presentation of the informed consent and witnessed the subject’s agreement to 
participate in the study. 
 
Signature of Witness:  
 
Printed Name of Witness:  
 
Date:   
 
 
 
If the subject is not English speaking and signed the translated Short Form in lieu of the English consent 
document. 
As someone who understands both English and the language spoken by the subject, I interpreted, in the subject’s 
language, the researcher’s presentation of the English consent form.  The subject was given the opportunity to ask 
questions.  
Signature of Interpreter:  
 
Printed name of Interpreter:  
 
Date:  
 
 
 
 
 
 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
06/23/2020