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NCT Number: NCT06831539

Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery

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

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location status: Recruiting

Location contact

Alysé Filin, MSc

CONTACT

[email protected]

5148908000 ext. 27031

Arielle Elkrief, MD

PRINCIPAL_INVESTIGATOR

Wiam Belkaid, PhD

CONTACT

[email protected]

514-890-8000 ext. 23242

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 to manufacturer labeling

Treatment and study plan

PEGLyte bowel preparation

Drug

Volunteers will be administered 4L of PEG bowel preparation. The following instructions will be provided with the prescription:

  • 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.
  • 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.
  • 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.
  • 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.

Other names: PEG

Primary outcomes

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

    Time frame: At week 1

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

Secondary outcomes

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

    Time frame: At 1 month and 3 months

    • Gut metabolite composition at 1 month after bowel preparation.
    • Gut microbiota composition, diversity, metabolite composition at 1 month and 3 months after bowel preparation

Study contacts

Contact information is provided by the study sponsor or research team.

Alysé Filin, MSc

CONTACT

[email protected]

514 890 8000 ext. 27031

Wiam Belkaid, PhD

CONTACT

[email protected]

514-890-8000 ext. 23242

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Acronym: PEG

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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