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

NCT06114303 | Terminated

• 1 other identifier: PIL-RIPH3-EPROMED-023
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysbiosis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

"Mother"

Healthy women

Other: Stool sampling

"Daughter"

Healthy "daughter" from "Mother" subjects

Other: Stool sampling

Interventions

Stool sampling OTHER

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

"Daughter"; "Mother"

Eligibility Criteria

• Age: 1 Year - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adult "Mother" population:
• Women aged 25-40 years;
• 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
• With a regular stool frequency (at least once every 2 days)
• Whose mother does not object to the collection and processing of personal data

You may not qualify if:

• 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 PPI, or having stopped it less than one month before.
• Persons under court protection,
• 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.
• On dietary supplements (prebiotics or probiotics) or having stopped them within the last month

Sponsors & Collaborators

• Larena SAS: lead
• Université Paris-Saclay: collaborator

Study Sites (1)

Amandine FRY

Dijon, 21000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: November 2, 2023
• Study Start: March 14, 2024
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)