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Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota

Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06114303
Acronym
EPROMED
Enrollment
14
Registered
2023-11-02
Start date
2024-03-14
Completion date
2025-06-16
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysbiosis

Brief 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 children) re-cultured under anaerobic conditions.

Interventions

OTHERStool sampling

1 stool sample is taken during the study with a stool sample kit

Sponsors

Université Paris-Saclay
CollaboratorOTHER
Larena SAS
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
1 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

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 * 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

Exclusion criteria

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. * 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

Design outcomes

Primary

MeasureTime frameDescription
Transcriptional activity of microbiomes10 monthsTranscriptional activity of microbiomes by sequencing of 16S rRNA vs. the gene encoding 16S rRNA
Transcriptomic profiles of the communities10 monthsTranscriptomic profiles of the communities assessed by meta-transcriptomics
Metabolites produced and microbial metabolic pathways10 monthsMetabolites produced and microbial metabolic pathways will be assessed by global metabolomics

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026