---
title: Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery
nct_id: NCT06831539
overall_status: RECRUITING
phase: PHASE1
sponsor: "Centre hospitalier de l'Université de Montréal (CHUM)"
study_type: INTERVENTIONAL
primary_condition: Cancer
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06831539.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06831539"
ct_last_update_post_date: 2025-02-19
last_seen_at: "2026-05-12T07:13:53.114Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery

**NCT ID:** [NCT06831539](https://clinicaltrials.gov/study/NCT06831539)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Centre hospitalier de l'Université de Montréal (CHUM)
- **Conditions:** Cancer, Healthy Participants
- **Start Date:** 2024-12-05
- **Completion Date:** 2026-12-05
- **CT.gov Last Update:** 2025-02-19

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **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.

## 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.

## Primary Outcomes

- **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

- **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)_

## Locations (1)

- Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.centre hospitalier de l'université de montréal (chum)|montreal|quebec|canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06831539.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06831539*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*