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The main objective is to evaluate the impact of intestinal preparation on the composition, diversity and metabolome of the intestinal microbiota.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEGLyte bowel preparation | Drug | Volunteers will be administered 4L of PEG bowel preparation. The following instructions will be provided with the prescription:
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the impact of bowel preparation on the gut microbiota at 1 week after bowel preparation. | Study of the gut microbiota composition at 1 week after bowel preparation. | At week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome composition, diversity, and gut metabolome profile at 1 month and 3 months after bowel preparation |
| At 1 month and 3 months |
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Inclusion Criteria:
Healthy volunteer participant cohort:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wiam Belkaid, PhD | Contact | 514-890-8000 | 23242 | wiam.belkaid.chum@ssss.gouv.qc.ca |
| Alysé Filin, MSc | Contact | 514 890 8000 | 27031 | alyse.filin.chum@ssss.gouv.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Arielle Elkrief, MD | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier de l'Université de Montréal (CHUM) | Recruiting | Montreal | Quebec | H2X 3E4 | Canada |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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This is a single-arm study evaluating the impact of PEG bowel preparation on the gut microbiome in volunteer participants.
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