Effects and Tolerability With Clenpiq and Low Residue Diet

Hillmont GI154 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

154

Conditions

Colonoscopy Preparation

Interventions

Low Residue DietOTHER

Variable cohort will eat 3 low residue meals on the day prior to their planned colonoscopy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hillmont GI

Flourtown, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: During Colonoscopy Up to 24 hours

Secondary Outcomes

Polyp Detection Rate

Number of polyps detected and removed per total number of patients in each arm

Time frame: Post Procedure Up to 24 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.