Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery

Last updated: February 17, 2025
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Overall Status: Active - Recruiting

Phase

1

Condition

Cancer

Treatment

PEGLyte bowel preparation

Clinical Study ID

NCT06831539
2025-12213
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy volunteer participant cohort:

  1. > 18 years of age

  2. The participant has provided documented informed consent for the participationand to complete PEG bowel preparation and return collected stool samples.

Exclusion

Exclusion Criteria:

  • 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 tomanufacturer labeling

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: PEGLyte bowel preparation
Phase: 1
Study Start date:
December 05, 2024
Estimated Completion Date:
December 05, 2026

Study Description

Based on the limited literature that PEG does not significantly impact the microbiome, certain investigators ascertain that administration of PEG without any subsequent FMT would represents the gold-standard control group. On the other hand, other investigators raised their concern that perturbation of the microbiome with PEG without subsequent replacement with FMT might negatively impact immune checkpoint inhibitor efficacy. Therefore, there is an unmet need to conduct a study using the metagenomic shotgun sequencing to precisely understand the impact of bowel preparation on gut microbiome composition and on the dynamics of recovery of the gut microbiome after bowel preparation to better design microbiome-centered trials.

Connect with a study center

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

    Montreal, Quebec H2X 3E4
    Canada

    Active - Recruiting

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