Effects and Tolerability With Clenpiq and Low Residue Diet

Study Overview
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Brief Summary
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The Efficacy of Clenpiq utilized per FDA labeling, with a low residue diet the day before colonoscopy.

Detailed Description
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This study proposes to assess the use of a low residue diet of a prescribed nature the day before colonoscopy for breakfast, lunch and early dinner. Clinical outcomes utilizing the low residue diet will be compared to the Food and Drug Administration (FDA) approved split dose labeling, including the traditional clear liquid diet the day before colonoscopy utilizing the Clenpiq (Ferring Pharmaceuticals) bowel preparation.

Official Title
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The Effects and Tolerability of a Prescribed Low Residue Diet the Day Before Colonoscopy on the Cleanliness of the Colon vs. the Traditional Clear Liquid, Day Before Diet With the Use of the Clenpiq Bowel Purgative

Conditions
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Colonoscopy Preparation

Intervention / Treatment
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* Other: Low Residue Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects age 18-80 requiring colonoscopy for appropriate indications Exclusion Criteria: Active diarrhea (Greater than 3 unformed stools daily) Constipation (Less than 3 spontaneous bowel movements per week) Each within 2 weeks of the scheduled Colonoscopy. Additional exclusion criteria would include; Subjects with a history of inflammatory bowel disease Colonic resection of any length Pregnant women American Society of Anesthesiologists (ASA) score greater than 3 Body Mass Index (BMI) greater than 50 Previous reaction to this bowel preparation or contraindications to taking Clenpiq per the package labeling guidelines. Subjects unable to give their own informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single blind trial of FDA approved preparation with per labeling clear liquid diet versus a single day low residue diet
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Clear Liquid Arm<br>Following instructions with FDA-labeled clear liquids | Other: Low Residue Diet<br>* Variable cohort will eat 3 low residue meals on the day prior to their planned colonoscopy<br>|
| Experimental: Low Residue Diet Arm<br>Following instructions for a low residue diet along with FDA-labeled clear liquids | Other: Low Residue Diet<br>* Variable cohort will eat 3 low residue meals on the day prior to their planned colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistical equivalence of the clear liquid and low residue cohorts | Using the Boston Bowel Preparation Score, the 3 sections of the colon will be graded on adequacy of preparation at the colonoscopy | During Colonoscopy Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp Detection Rate | Number of polyps detected and removed per total number of patients in each arm | Post Procedure Up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low residue diet