Stool Collection From Healthy Donors for the ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota: Bacteria / Host Interaction Model
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 4
- Primary Endpoint
- PH evolution
Study Overview
Brief Summary
To design and understand the mechanism of action of different combinations of nutraceuticals coupling bacteria, fibers and polyphenols, which can act on the 4 pillars simultaneously via an innovative ex-vivo model approach coupled with functional and quantitative metagenomics.
Detailed Description
The objective of the study is to collect fresh stools from 4 healthy volunteers, in order to study the mechanism of action of probiotic strains, polyphenols and fibers, alone or in combinations. These fresh stools will be cultured in vitro in fermenters, and the samples taken at different culture times will be analyzed in terms of microbial composition (shotgun metagenomic analysis) and their cellular activity (functional metagenomic analysis).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Person with a low fiber diet (<17g / day).
Exclusion Criteria
- •Taking antibiotics and / or transit modulators in the 3 months preceding the sample;
- •Colonoscopy in the last 3 months;
- •Person under legal protection measure (curators, tutors, etc.).
Outcomes
Primary Outcomes
PH evolution
Time Frame: Day 1 to Day 15
Change about the PH evolution after 15 days of incubation
Quantity of Co2 production
Time Frame: Day 1 to Day 15
Change about the quantity of Co2 production after 15 days of incubation
Bacterial growth
Time Frame: Day 1 to Day 15
Change about the bacterial growth after 15 days of incubation
Secondary Outcomes
No secondary outcomes reported