Ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04895774

Enrollment

Registered

2021-05-20

Start date

2021-09-30

Completion date

2021-10-31

Last updated

2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbial Colonization

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).

Interventions

OTHERProbiotic strains

Fresh stools will be cultured in vitro in fermenters with adjunction of probiotic strains

OTHERPolyphenols

Fresh stools will be cultured in vitro in fermenters with adjunction of polyphenols

OTHERFibers

Fresh stools will be cultured in vitro in fermenters with adjunction of fibers

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.).

Design outcomes

Primary

Measure	Time frame	Description
Bacterial growth	Day 1 to Day 15	Change about the bacterial growth after 15 days of incubation
PH evolution	Day 1 to Day 15	Change about the PH evolution after 15 days of incubation
Quantity of Co2 production	Day 1 to Day 15	Change about the quantity of Co2 production after 15 days of incubation

Contacts

Primary ContactHervé Blottière

herve.blottiere@inrae.fr06.19.32.28.72

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026