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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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