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
• Status: Not yet recruiting
• 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
• 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.).

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Microbial Colonization

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