Cancer, Healthy Participants
Conditions
Keywords
PegLyte, Microbiome
Brief summary
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.
Interventions
DRUGPEGLyte 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.
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-arm study evaluating the impact of PEG bowel preparation on the gut microbiome in volunteer participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the impact of bowel preparation on the gut microbiota at 1 week after bowel preparation. | At week 1 | Study of the gut microbiota composition at 1 week after bowel preparation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiome composition, diversity, and gut metabolome profile at 1 month and 3 months after bowel preparation | At 1 month and 3 months | 1. Gut metabolite composition at 1 month after bowel preparation. 2. Gut microbiota composition, diversity, metabolite composition at 1 month and 3 months after bowel preparation |
Countries
Canada
Contacts
Primary ContactWiam Belkaid, PhD
Backup ContactAlysé Filin, MSc
Outcome results
None listed