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Clinical Trials in Canada / NCT06831539
Recruiting Phase 1

Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery

NCT06831539 · tracked via the Priya Life Science Canada tracker
Phase
Phase 1
Started
2024-12-05
Last updated
2025-02-19

Condition(s) studied

CancerHealthy Participants

Investigational drug(s) / intervention(s)

PEGLyte bowel preparation

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Centre hospitalier de l'Université de Montréal (CHUM) Montreal Quebec Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06831539 on ClinicalTrials.gov ↗ ← All trials in Canada