Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery

NCT06831539 | Recruiting Phase 1

• 1 other identifier: 2025-12213
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to evaluate the impact of intestinal preparation on the composition, diversity and metabolome of the intestinal microbiota.

Conditions

Cancer; Healthy Participants

Keywords

PegLyte; Microbiome

Outcome Measures

Primary Outcomes (1)

• To evaluate the impact of bowel preparation on the gut microbiota at 1 week after bowel preparation.

  Study of the gut microbiota composition at 1 week after bowel preparation.

  At week 1

Secondary Outcomes (1)

• Gut microbiome composition, diversity, and gut metabolome profile at 1 month and 3 months after bowel preparation

  At 1 month and 3 months

Study Arms (1)

Healthy volunteer participant cohort

EXPERIMENTAL

For healthy volunteer participants, PEG bowel preparation will be administered and participants will collect stool samples before and after PEG at specified timepoints.

Drug: PEGLyte bowel preparation

Interventions

PEGLyte bowel preparation DRUG

Volunteers will be administered 4L of PEG bowel preparation. The following instructions will be provided with the prescription: 1. Fill the supplied container containing the bowel cleanse powder with lukewarm water (to facilitate dissolution) to the 4-liter fill line. The solution is clear and colourless when reconstituted to a final volume of 4 liters. 2. After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. The solution is more palatable if chilled prior to drinking. When reconstituted use within 48 hours. 3. Attempt to drink a maximum of 4 liters at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters has been consumed or the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. 4. The first bowel movements should occur approximately one hour after the start of bowel cleanse administration. Continue drinking until the watery stool is clear and free of solid matter.

Also known as: PEG

Healthy volunteer participant cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteer participant cohort:
• \> 18 years of age
• The participant has provided documented informed consent for the participation and to complete PEG bowel preparation and return collected stool samples.

You may not qualify if:

• An ileus
• Significant gastric retention
• Suspected or established mechanical bowel obstruction
• Inflammatory or infectious gastrointestinal condition
• Neurologic or cognitive impairment that prevents safe swallowing
• Recent history (\<1 year) of cancer that still requires ongoing treatment
• Recent use of antibiotics 1 month prior to participation in the trial
• History of cardiac disease
• History of active renal dysfunction
• Presence of any absolute contraindication to PEG bowel preparation according to manufacturer labeling

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Arielle Elkrief, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wiam Belkaid, PhD

CONTACT

514-890-8000; wiam.belkaid.chum@ssss.gouv.qc.ca

Alysé Filin, MSc

CONTACT

514 890 8000; alyse.filin.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm study evaluating the impact of PEG bowel preparation on the gut microbiome in volunteer participants.

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: December 5, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 5, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

CA (1)