Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota
Not yet recruiting
- Conditions
- Dysbiosis
- Interventions
- Other: Stool sampling
- Registration Number
- NCT06114303
- Lead Sponsor
- Larena SAS
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 40
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description "Mother" Stool sampling Healthy women "Daughter" Stool sampling Healthy "daughter" from "Mother" subjects
- Primary Outcome Measures
Name Time Method Transcriptomic profiles of the communities 10 months Transcriptomic profiles of the communities assessed by meta-transcriptomics
Metabolites produced and microbial metabolic pathways 10 months Metabolites produced and microbial metabolic pathways will be assessed by global metabolomics
Transcriptional activity of microbiomes 10 months Transcriptional activity of microbiomes by sequencing of 16S rRNA vs. the gene encoding 16S rRNA
- Secondary Outcome Measures
Name Time Method