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

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 Overview

• Status: Terminated
• Conditions: Dysbiosis
• Intervention / Treatment: Other: Stool sampling

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Amandine FRY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The mother/daughter " duos " participating in the study will be drawn from a panel of volunteers.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
"Mother"; Healthy women	Other: Stool sampling; 1 stool sample is taken during the study with a stool sample kit
"Daughter"; Healthy "daughter" from "Mother" subjects	Other: Stool sampling; 1 stool sample is taken during the study with a stool sample kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcriptional activity of microbiomes	Transcriptional activity of microbiomes by sequencing of 16S rRNA vs. the gene encoding 16S rRNA	10 months
Transcriptomic profiles of the communities	Transcriptomic profiles of the communities assessed by meta-transcriptomics	10 months
Metabolites produced and microbial metabolic pathways	Metabolites produced and microbial metabolic pathways will be assessed by global metabolomics	10 months

Collaborators and Investigators

• Sponsor: Larena SAS
• Collaborators: Université Paris-Saclay

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2024
• Primary Completion (Actual): June 16, 2025
• Study Completion (Actual): June 16, 2025

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dysbiosis
• Other Study ID Numbers: PIL-RIPH3-EPROMED-023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No