NCT06831539 Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery
| NCT ID | NCT06831539 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-12-05 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-12-05 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main objective is to evaluate the impact of intestinal preparation on the composition, diversity and metabolome of the intestinal microbiota.
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
Contact & Investigator
Arielle Elkrief, MD
PRINCIPAL INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Frequently Asked Questions
Who can join the NCT06831539 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06831539 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06831539 currently recruiting?
Yes, NCT06831539 is actively recruiting participants. Contact the research team at wiam.belkaid.chum@ssss.gouv.qc.ca for enrollment information.
Where is the NCT06831539 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT06831539 clinical trial?
NCT06831539 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The principal investigator is Arielle Elkrief, MD at Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 20 participants.
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