DysbiosisEPROMEDNCT06114303
Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota
An observational study of Dysbiosis, run by Larena SAS at 1 site in France.
Trial summary
The objective is to test ex-vivo the effects of two probiotic solutions (Lactibiane ATB and Lactibiane Enfant) and five classes of drugs (antibiotic, proton pump inhibitor, non-steroidal anti-inflammatory, anxiolytic and anti-depressant) on microbial microcosms derived from human stool samples (from adults and… Read more about this study
- Who is it for?
- Ages 1 year to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysbiosis
- What is being tested?
- Stool sampling
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2024to 16 Jun 2025
- 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 1 year to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The mother/daughter " duos " participating in the study will be drawn from a panel of volunteers.
Who may be able to join
- Adult "Mother" population:
- Women aged 25-40 years;
- In good general health, i.e. no chronic pathology and not taking any medication at the time of inclusion and/or long-term treatment,
- With a regular bowel movement frequency (at least once every 2 days)
- BMI between 18.5 and 25
- Able and willing to participate in the research by complying with the protocol procedures
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- Not objecting to the collection and processing of their personal data
- Child "Daughter" population
- Girl between 1 and 2 years old
- In good general health, i.e. no chronic pathology and not taking any medication at the time of inclusion and/or on a long-term basis,
- With a regular stool frequency (at least once every 2 days)
- Whose mother does not object to the collection and processing of personal data
Who cannot join
- Adult "Mother" population :
- Pregnant or breastfeeding women,
- Under antibiotic treatment, or having stopped it for less than a month.
- Under dietary supplementation (prebiotics or probiotics) or having stopped it less than one month before
- On antidepressants and/or anxiolytics in the month before inclusion
- Taking a non-steroidal anti-inflammatory drug (NSAID) the month before inclusion.
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- On PPI, or having stopped it less than one month before.
- Persons under court protection,
- Person participating in another research study with an ongoing exclusion period,
- Child "Daughter" population:
- Outside the WHO normal growth charts (weight for height) for girls aged 0-2 years (below the 3rd percentile or above the 97th percentile)
- Undergoing antibiotic treatment, or having stopped it less than a month ago.
- Having taken a non-steroidal anti-inflammatory drug (NSAID) in the month prior to inclusion.
- On dietary supplements (prebiotics or probiotics) or having stopped them within the last month
- Subjects participating in another research study with an ongoing exclusion period
Trial locations and contacts
1 site in 1 country.
About this study
The objective is to test ex-vivo the effects of two probiotic solutions (Lactibiane ATB and Lactibiane Enfant) and five classes of drugs (antibiotic, proton pump inhibitor, non-steroidal anti-inflammatory, anxiolytic and anti-depressant) on microbial microcosms derived from human stool samples (from adults and children) re-cultured under anaerobic conditions.
- Conditions
- Dysbiosis
- Being tested
- Stool sampling
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool samplingOther
1 stool sample is taken during the study with a stool sample kit
| Study group | Role | What they receive |
|---|---|---|
| "Mother" | Healthy women Receives: Other: Stool sampling | |
| "Daughter" | Healthy "daughter" from "Mother" subjects Receives: Other: Stool sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptional activity of microbiomes
Transcriptional activity of microbiomes by sequencing of 16S rRNA vs. the gene encoding 16S rRNA
Measured: 10 months
Transcriptomic profiles of the communities
Transcriptomic profiles of the communities assessed by meta-transcriptomics
Measured: 10 months
Metabolites produced and microbial metabolic pathways
Metabolites produced and microbial metabolic pathways will be assessed by global metabolomics
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start14 Mar 2024
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Why it stopped: This study was terminated early on 16/06/2025 because the initial results obtained from the 14 pairs of patients included were sufficient to satisfactorily address the research question posed in the context of the thesis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysbiosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larena SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Université Paris-Saclay
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114303
- Sponsor's protocol ID
- PIL-RIPH3-EPROMED-023
- Acronym
- EPROMED
- Status last verified
- Jul 2025
- First submitted
- 27 Feb 2023
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota
- ClinicalTrials.gov ID
- NCT06114303
- Acronym / sponsor ID
- EPROMED / PIL-RIPH3-EPROMED-023
- Conditions
- Dysbiosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was terminated early on 16/06/2025 because the initial results obtained from the 14 pairs of patients included were sufficient to satisfactorily address the research question posed in the context of the thesis.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Larena SASIndustry (pharma, biotech, devices)
- Collaborators
- Université Paris-Saclay
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 2 Nov 2023 (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.
The objective is to test ex-vivo the effects of two probiotic solutions (Lactibiane ATB and Lactibiane Enfant) and five classes of drugs (antibiotic, proton pump inhibitor, non-steroidal anti-inflammatory, anxiolytic and anti-depressant) on microbial microcosms derived from human stool samples (from adults and children) re-cultured under anaerobic conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Mother" | – | Other: Stool samplingHealthy women |
| "Daughter" | – | Other: Stool samplingHealthy "daughter" from "Mother" subjects |
Who may qualify
- Ages
- 1 year to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The mother/daughter " duos " participating in the study will be drawn from a panel of volunteers.
Key inclusion criteria (12 listed)
- Women aged 25-40 years;
- In good general health, i.e. no chronic pathology and not taking any medication at the time of inclusion and/or long-term treatment,
- With a regular bowel movement frequency (at least once every 2 days)
- BMI between 18.5 and 25
- Able and willing to participate in the research by complying with the protocol procedures
Key exclusion criteria (15 listed)
- Pregnant or breastfeeding women,
- Under antibiotic treatment, or having stopped it for less than a month.
- Under dietary supplementation (prebiotics or probiotics) or having stopped it less than one month before
- On antidepressants and/or anxiolytics in the month before inclusion
- Taking a non-steroidal anti-inflammatory drug (NSAID) the month before inclusion.
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 |
|---|---|---|
| Stool sampling1 stool sample is taken during the study with a stool sample kit | Other | "Daughter", "Mother" |
Primary outcome
Transcriptional activity of microbiomes
Time frame: 10 months
Transcriptional activity of microbiomes by sequencing of 16S rRNA vs. the gene encoding 16S rRNA
Transcriptomic profiles of the communities
Time frame: 10 months
Transcriptomic profiles of the communities assessed by meta-transcriptomics
Metabolites produced and microbial metabolic pathways
Time frame: 10 months
Metabolites produced and microbial metabolic pathways will be assessed by global metabolomics
Results and safety
The study was stopped early (reason given: This study was terminated early on 16/06/2025 because the initial results obtained from the 14 pairs of patients included were sufficient to satisfactorily address the research question posed in the context of the thesis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysbiosis, run by Larena SAS at 1 site in France.
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 12 inclusion and 15 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: stopped early, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: This study was terminated early on 16/06/2025 because the initial results obtained from the 14 pairs of patients included were sufficient to satisfactorily address the research question posed in the context of the thesis.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptional activity of microbiomes (time frame: 10 months). 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 2 Dec 2025.