Effects and Tolerability With Clenpiq and Low Residue Diet

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04150133

Enrollment

154

Registered

2019-11-04

Start date

2019-11-21

Completion date

2021-10-01

Last updated

2022-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy Preparation

Keywords

low residue diet

Brief summary

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

Detailed 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.

Interventions

OTHERLow Residue Diet

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Investigator)

Masking description

Investigator will be ignorant of how preparation was taken

Intervention model description

single blind trial of FDA approved preparation with per labeling clear liquid diet versus a single day low residue diet

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026