CancerPhase 1PEGNCT06831539
Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery
A Phase 1 study testing PEGLyte bowel preparation in people with Cancer and Healthy Participants, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The main objective is to evaluate the impact of intestinal preparation on the composition, diversity and metabolome of the intestinal microbiota. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Healthy Participants
- What is being tested?
- PEGLyte bowel preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 5 Dec 2024to 25 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
About this study
The main objective is to evaluate the impact of intestinal preparation on the composition, diversity and metabolome of the intestinal microbiota.
Read the 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.
- Conditions
- Cancer, Healthy Participants
- Being tested
- PEGLyte bowel preparation
- Keywords
- PegLyte, Microbiome
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEGLyte bowel preparationDrug
Also called PEG
Volunteers will be administered 4L of PEG bowel preparation. The following instructions will be provided with the prescription:
- 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.
- 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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: PEGLyte bowel preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage changes in Gut Metabolite Concentrations at 1 Month After Bowel Preparation
Study of the gut microbiota composition at 1 week after bowel preparation.
Measured: At week 1
Secondary outcomes (1)
Percentage changes in Gut Microbiota Composition, Diversity, and Metabolite Concentrations at 1 Month and 3 Months After Bowel Preparation
- Gut metabolite composition at 1 month after bowel preparation.
- Gut microbiota composition, diversity, metabolite composition at 1 month and 3 months after bowel preparation
Measured: At 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start5 Dec 2024
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm study evaluating the impact of PEG bowel preparation on the gut microbiome in volunteer participants.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arielle Elkrief, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831539
- Sponsor's protocol ID
- 2025-12213
- Other IDs
- 2025
- Acronym
- PEG
- Status last verified
- Jul 2025
- First submitted
- 13 Feb 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery
- ClinicalTrials.gov ID
- NCT06831539
- Acronym / sponsor ID
- PEG / 2025-12213
- Conditions
- Cancer, Healthy Participants
- Keywords
- PegLyte, Microbiome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm study evaluating the impact of PEG bowel preparation on the gut microbiome in volunteer participants.
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer participant cohort | Experimental | Drug: PEGLyte bowel preparationFor healthy volunteer participants, PEG bowel preparation will be administered and participants will collect stool samples before and after PEG at specified timepoints. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteer participant cohort:
Key exclusion criteria (10 listed)
- An ileus
- Significant gastric retention
- Suspected or established mechanical bowel obstruction
- Inflammatory or infectious gastrointestinal condition
- Neurologic or cognitive impairment that prevents safe swallowing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEGLyte bowel preparationAlso: PEGVolunteers 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. | Drug | Healthy volunteer participant cohort |
Primary outcome
Percentage changes in Gut Metabolite Concentrations at 1 Month After Bowel Preparation
Time frame: At week 1
Study of the gut microbiota composition at 1 week after bowel preparation.
1 secondary outcome
Percentage changes in Gut Microbiota Composition, Diversity, and Metabolite Concentrations at 1 Month and 3 Months After Bowel Preparation
Time frame: At 1 month and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arielle Elkrief, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEGLyte bowel preparation in people with Cancer and Healthy Participants, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage changes in Gut Metabolite Concentrations at 1 Month After Bowel Preparation (time frame: At week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.