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NCT04895774 Clinical Trial

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

Microbial Colonization Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04895774
Other study ID # 2021-A00700-41
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2021
Est. completion date October 2021

Study information
Verified date August 2021
Source Nutri & Co
Contact Hervé Blottière
Phone 06.19.32.28.72
Email herve.blottiere@inrae.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 4
Est. completion date October 2021
Est. primary completion date October 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Probiotic strains
Fresh stools will be cultured in vitro in fermenters with adjunction of probiotic strains
• Polyphenols
Fresh stools will be cultured in vitro in fermenters with adjunction of polyphenols
• Fibers
Fresh stools will be cultured in vitro in fermenters with adjunction of fibers

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Nutri & Co

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