Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG). (POG)

February 13, 2026 updated by: Clinique Paris-Bercy

A Single-blind, Randomized Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).

Low-residue diet (LRD) in patient improves the quality of the colon cleanliness and thus the adenoma detection rate (ADR). This is a key criterion in colonoscopy screening for colorectal cancer (CRC). The benefit of an LRD lasting more than 24 hours before colonoscopy has not been demonstrated compared to a 24-hour LRD.

Few studies have evaluated the benefit of a prepackaged 24-hour LRD compared to simply receiving oral and written LRD instructions during a consultation.

The aim of the study is to evaluate the usefulness of a prepackaged LRD (Colobox®) compared to simple LRD instructions on colon cleanliness (Boston score) in patients examined by endoscopy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Charenton-le-Pont, France, 94220

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient of one of the investigators for total colonoscopy (no prior colonic surgery);
  • Patient aged 18 years or older;
  • Patient classified as ASA 1, ASA 2, or ASA 3;
  • Not participating in any other current clinical trial;
  • Free, informed, and signed consent;
  • Patient affiliated with or a beneficiary of a social security scheme, according to Article L.1124-1 of the French Public Health Code;

Exclusion Criteria:

  • Patient taking major psychotropic medications;
  • Patient with uncontrolled diabetes;
  • Patient with coagulation abnormalities preventing polypectomy: PT <50%, Platelets <50,000/mm³, current effective anticoagulation therapy (clopidogrel, prasugrel, or ticagrelor);
  • Patient referred for removal of a known polyp;
  • Chronic inflammatory bowel disease;
  • Known colonic stenosis;
  • Diverticulitis of less than 6 weeks duration;
  • Pregnant, parturient, or breastfeeding woman;
  • Patient deprived of liberty by administrative or judicial order, or under guardianship or limited legal protection;
  • Patient unable to understand the objectives and constraints of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient with LRD prepared 24 hours before colonoscopy
The LRD prepared is Colobox
Procedure: Colonoscopy
Colonoscopy performed and Boston score evaluated
Other: Questionnaires
LRD satisfaction questionnaire LRD compliance questionnaire
Other: Pre-colonoscopy diet by following a special preparation, Colobox.
24 hours before the colonoscopy, The patients follow a special diet, by following a special preparation, Colobox.
Active Comparator: Patients with not prepared LRD, 24 hours before colonoscopy
The LRD is only explained orally and in writing to the patient
Procedure: Colonoscopy
Colonoscopy performed and Boston score evaluated
Other: Questionnaires
LRD satisfaction questionnaire LRD compliance questionnaire
Other: Pre-colonoscopy diet according to the investigator's oral instructions
24 hours before the colonoscopy, The patients follow a special diet, either by themselves according to the investigator's oral instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Boston Score
Time Frame: 1 day

A 9-point system, helps them see how clean a patient's large intestine is during a colonoscopy. This scale divides the large intestine into three parts: right, middle, and left.

Each part can score from :

BBPS = 0 (per segment) : unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared.

BPPS=3 (per segment) : entire mucosa of the colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Paris-Bercy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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