Microbial ColonizationNCT04895774
Ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota
An observational study of Microbial Colonization, run by Nutri & Co.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Probiotic strains, Polyphenols and Fibers
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Person with a low fiber diet (<17g / day).
Who cannot join
- 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.).
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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).
- Conditions
- Microbial Colonization
- Being tested
- Probiotic strains, Polyphenols, Fibers
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic strainsOther
Fresh stools will be cultured in vitro in fermenters with adjunction of probiotic strains
PolyphenolsOther
Fresh stools will be cultured in vitro in fermenters with adjunction of polyphenols
FibersOther
Fresh stools will be cultured in vitro in fermenters with adjunction of fibers
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial growth
Change about the bacterial growth after 15 days of incubation
Measured: Day 1 to Day 15
PH evolution
Change about the PH evolution after 15 days of incubation
Measured: Day 1 to Day 15
Quantity of Co2 production
Change about the quantity of Co2 production after 15 days of incubation
Measured: Day 1 to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study startSep 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutri & Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895774
- Sponsor's protocol ID
- 2021-A00700-41
- Status last verified
- Aug 2021
- First submitted
- 17 May 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04895774
- Acronym / sponsor ID
- 2021-A00700-41
- Conditions
- Microbial Colonization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Nutri & CoIndustry (pharma, biotech, devices)
- Study start
- Sep 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Person with a low fiber diet (<17g / day).
Key exclusion criteria (3 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic strainsFresh stools will be cultured in vitro in fermenters with adjunction of probiotic strains | Other | – |
| PolyphenolsFresh stools will be cultured in vitro in fermenters with adjunction of polyphenols | Other | – |
| FibersFresh stools will be cultured in vitro in fermenters with adjunction of fibers | Other | – |
Primary outcome
Bacterial growth
Time frame: Day 1 to Day 15
Change about the bacterial growth after 15 days of incubation
PH evolution
Time frame: Day 1 to Day 15
Change about the PH evolution after 15 days of incubation
Quantity of Co2 production
Time frame: Day 1 to Day 15
Change about the quantity of Co2 production after 15 days of incubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Colonization, run by Nutri & Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hervé Blottière (06.19.32.28.72, herve.blottiere@inrae.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial growth (time frame: Day 1 to Day 15). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.