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
1 other identifier
observational
4
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2021
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedSeptember 1, 2021
August 1, 2021
1 month
May 17, 2021
August 31, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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
Interventions
Fresh stools will be cultured in vitro in fermenters with adjunction of probiotic strains
Fresh stools will be cultured in vitro in fermenters with adjunction of polyphenols
Fresh stools will be cultured in vitro in fermenters with adjunction of fibers
Eligibility Criteria
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.
You may qualify if:
- Person with a low fiber diet (\<17g / day).
You may not qualify if:
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nutri & Colead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2021
First Posted
May 20, 2021
Study Start
September 1, 2021
Primary Completion
October 1, 2021
Study Completion
October 1, 2021
Last Updated
September 1, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share