Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PEGLyte bowel preparation.
- Who it may be relevant to
- Registry conditions: Cancer, Healthy Participants. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug 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
Primary outcome measures
- To evaluate the impact of bowel preparation on the gut microbiota at 1 week after bowel preparation. [Time frame: At week 1]
Secondary outcome measures (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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Centre hospitalier de l'Université de Montréal (CHUM) — Montreal
Identifiers
NCT: NCT06831539 · 2025-12213