EPROMED: Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Transcriptional activity of microbiomes [10 months]
Transcriptional activity of microbiomes by sequencing of 16S rRNA vs. the gene encoding 16S rRNA
- 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
Eligibility Criteria
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,
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With a regular bowel movement frequency (at least once every 2 days)
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BMI between 18.5 and 25
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Able and willing to participate in the research by complying with the protocol procedures
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Not objecting to the collection and processing of their personal data
Child "Daughter" population
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Girl between 1 and 2 years old
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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,
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With a regular stool frequency (at least once every 2 days)
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Whose mother does not object to the collection and processing of personal data
Exclusion Criteria:
Adult "Mother" population :
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Pregnant or breastfeeding women,
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Under antibiotic treatment, or having stopped it for less than a month.
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Under dietary supplementation (prebiotics or probiotics) or having stopped it less than one month before
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On antidepressants and/or anxiolytics in the month before inclusion
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Taking a non-steroidal anti-inflammatory drug (NSAID) the month before inclusion.
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On PPI, or having stopped it less than one month before.
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Persons under court protection,
-
Person participating in another research study with an ongoing exclusion period,
Child "Daughter" population:
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Outside the WHO normal growth charts (weight for height) for girls aged 0-2 years (below the 3rd percentile or above the 97th percentile)
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Larena SAS
- Université Paris-Saclay
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PIL-RIPH3-EPROMED-023