Effects and Tolerability With Clenpiq and Low Residue Diet

Colonoscopy Preparation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150133
• Other study ID #: foodprep2019
• Status: Completed
• Phase: N/A
• Start date: November 21, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: March 2022
• Source: Hillmont GI
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: October 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonoscopy Preparation

Intervention

Other:
• Low Residue Diet
Variable cohort will eat 3 low residue meals on the day prior to their planned colonoscopy

Locations

Country	Name	City	State
United States	Hillmont GI	Flourtown	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Hillmont GI	Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Polyp Detection Rate	Number of polyps detected and removed per total number of patients in each arm	Post Procedure Up to 24 hours