Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery

NCT ID: NCT06831539

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-05
• Study Completion Date: 2026-12-05

Brief Summary

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

Detailed 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.

Conditions

Cancer; Healthy Participants

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy volunteer participant cohort

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

Group Type: EXPERIMENTAL

PEGLyte bowel preparation

Intervention Type: 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.

Interventions

PEGLyte bowel preparation

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.

Intervention Type: DRUG

Other Intervention Names

PEG

Eligibility Criteria

Inclusion Criteria

• Healthy volunteer participant cohort:

1. > 18 years of age

2. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arielle Elkrief, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Wiam Belkaid, PhD

Role: CONTACT

wiam.belkaid.chum@ssss.gouv.qc.ca

514-890-8000 ext. 23242

Alysé Filin, MSc

Role: CONTACT

alyse.filin.chum@ssss.gouv.qc.ca

514 890 8000 ext. 27031

Facility Contacts

Wiam Belkaid, PhD

Role: primary

wiam.belkaid.chum@ssss.gouv.qc.ca

514-890-8000 ext. 23242

Alysé Filin, MSc

Role: backup

alyse.filin.chum@ssss.gouv.qc.ca

5148908000 ext. 27031

Other Identifiers

2025-12213

Identifier Type: -

Identifier Source: org_study_id