Recruiting
Phase 1

Observational Study

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT06831539

Conditions

Cancer

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

PEGLyte bowel preparation

Study Details

Brief summary:

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

Conditions

Cancer

Healthy Participants

Study ID

NCT06831539

Start date

Dec 5, 2024

Status verified date

Feb, 2025

Completion date

Dec 5, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • To evaluate the impact of bowel preparation on the gut microbiota at 1 week after bowel preparation. [ Time Frame: At week 1 ]

Central Contacts and Locations

Locations

Centre hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Principal Investigator:

Arielle Elkrief, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Feb 19, 2025

Last verified

Feb, 2025

Keywords

  • PegLyte
  • Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2025-02-19.