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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Microbial Colonization
• Intervention / Treatment: Other: Probiotic strains; Other: Polyphenols; Other: Fibers

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 Type: Observational
• Enrollment (Anticipated): 4

Contacts and Locations

• Study Contact: Name: Hervé Blottière; Phone Number: 06.19.32.28.72; Email: herve.blottiere@inrae.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The research will be carried out on 4 healthy volunteers. The research will be carried out by the coordinating team of the INRAE MetaGenoPolis Unit.

Description

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.).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nutri & Co

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 2021-A00700-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No