2 Regimens of Lactulose for Colonoscopy Preparation in Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a preparation for colonoscopy.

Detailed Description
-----------------
A full-dose regimen of lactulose for oral solution, where all dosing is completed the evening prior to the colonoscopy procedure, will be studied and compared to a split-dose regimen, where three doses are taken on the prior evening, and one dose is taken the morning of the procedure.

Official Title
-----------------
A Randomized, Single-blind Pilot Study to Determine the Safety, Efficacy, and Patient Preference of 2 Regimens of Lactulose for Cleansing of the Colon as a Preparation for Colonoscopy in Adults

Conditions
-----------------
Colonoscopy Preparation

Intervention / Treatment
-----------------
* Drug: Full dose preparation
* Drug: Split dose preparation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring bowel evacuation for colonoscopy. Exclusion Criteria: Patients with galactosemia (galactose-sensitive diet). Patients known to be hypersensitive to any of the components of lactulose for oral solution. Patients with an abnormality on screening blood work or vital sign assessments that, in the Investigator's judgment, may pose a significant risk including those pertaining to dehydration or electrolyte shifts. Patients with a history of impaired renal function. Patients with current or recent history of hypotension, as defined by the Investigator. Patients with a history of long Q-T syndrome. Patients with a history of a failed bowel preparation. Patients with severe constipation, defined as those patients taking daily prescription or over-the-counter laxatives. Patients with possible bowel obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, ileus or previous colonic surgery. Patients on lactulose therapy or receiving any treatment for chronic constipation. Be pregnant or nursing. Patients with known large polyps or flat polyps (i.e. polyps requiring electrocautery or argon plasma coagulation). Patients less than 18 years of age. Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions. Be otherwise unsuitable for the study, in the opinion of the Investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full dose preparation; AM colonoscopy<br>Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated prior to noon on the following day. | Drug: Full dose preparation<br> <br> * Other names: Evening-only Regimen;|
| Experimental: Full dose preparation; PM colonoscopy<br>Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated after noon on the following day. | Drug: Full dose preparation<br> <br> * Other names: Evening-only Regimen;|
| Experimental: Split dose preparation; AM colonoscopy<br>Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon. | Drug: Split dose preparation<br> <br> |
| Experimental: Split dose preparation; PM colonoscopy<br>Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon. | Drug: Split dose preparation<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Lactulose as a Preparation for Colonoscopy. | Efficacy assessed by the physician's determination of the cleanliness of the colon using the cumulative Boston Bowel Preparation Scale (BBPS) score. The cumulative score is derived from three segmental scores assessed from the following three colonic segments: right colon, transverse colon, and left colon. Segment scores range from 0 to 3 with the following abbreviated definitions: 0=mucosa not visible; 1=a portion of the mucosa is visible; 2=minor residue, but mucosa is seen well; 3=entire mucosa is seen well with no residue. The cumulative BBPS score is the sum of the three segment scores such that a cumulative score of 9 represents a colon with maximum mucosa visible and a score of 0 represents minimal visibility. | at least 3 hours post last consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment Failure | A treatment failure is defined in the protocol as a bowel preparation that receives a cumulative Boston Bowel Preparation Score less than 5, or has one or more of the segments scored as a 0. | at least 3 hours post last consumption | 
| Tolerability of and Preference for Lactulose as a Bowel Evacuant-Patient Visual Analog Scale (VAS) | A paper questionnaire contained a horizontal line 100 mm long with the right end labeled Best Possible Experience and the left end labeled Worst Possible Experience. The patients were asked to use a pen to place a mark on the line at the point that best described their overall tolerability for the bowel preparation. Scores were determined by measuring the distance of the mark from the left end of the line. So, a lower number would indicate a poor experience and a high number would reflect a positive experience, with 100 being the maximum score and one that describes the best possible experience with the preparation. | 3 - 15 hours post last consumption | 
| Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 1 | Tolerability assessed by a patient questionnaire - Likert response to was regimen a tolerable bowel prep? Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree | 3-15 hours post last consumption | 
| Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 2 | Tolerability assessed by a patient questionnaire - Likert response to I did not experience too much discomfort during the bowel prep Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree | 3-15 hours post last consumption | 
| Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 3 | Tolerability assessed by a patient questionnaire - Likert response to The dosing instructions were easy to understand and follow Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree | 3 - 15 hours post last consumption | 
| Tolerability of and Preference for Lactulose as a Bowel Evacuant | Survey response to question: Would you be willing to repeat this preparation if a colonoscopy was felt to be medically necessary at some point in the future? The outcome measure is reporting the percentage of participants who replied Yes to this survey question. | 3 - 15 hours post last consumption | 
| Tolerability of and Preference for Lactulose as a Bowel Evacuant | Survey response to question: if you had a previous colonoscopy, please indicate your preference for the crystalline lactulose or the previous medications. | 3 to 15 hours post last consumption | 
| Colonic Hydrogen Gas Levels |  | 3 - 15 hours post last consumption | 
| Colonic Methane Gas Levels |  | 3 - 15 hours post last consumption | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bowel Evacuation, Colonoscopy Preparation