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

NCT ID: NCT06114303

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-14
• Study Completion Date: 2025-06-16

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

"Mother"

Healthy women

Stool sampling

Intervention Type: OTHER

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

"Daughter"

Healthy "daughter" from "Mother" subjects

Stool sampling

Intervention Type: OTHER

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

Interventions

Stool sampling

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Université Paris-Saclay

OTHER

Sponsor Role: collaborator

Larena SAS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Amandine FRY

Dijon, , France

Countries

France

Other Identifiers

PIL-RIPH3-EPROMED-023

Identifier Type: -

Identifier Source: org_study_id