Status:
TERMINATED
Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota
Lead Sponsor:
Larena SAS
Collaborating Sponsors:
Université Paris-Saclay
Conditions:
Dysbiosis
Eligibility:
FEMALE
1-40 years
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-inflamma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 16 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06114303
Start Date
March 14 2024
End Date
June 16 2025
Last Update
December 2 2025
Active Locations (1)
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1
Amandine FRY
Dijon, France, 21000