Dysbiosis Clinical Trial
— EPROMEDOfficial title:
Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota
Verified date | February 2023 |
Source | Larena SAS |
Contact | Quentin DAUCHET |
Phone | +33144388838 |
q.dauchet[@]pileje.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 1 Year to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Larena SAS | Université Paris-Saclay |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Transcriptional activity of microbiomes | Transcriptional activity of microbiomes by sequencing of 16S rRNA vs. the gene encoding 16S rRNA | 10 months | |
Primary | Transcriptomic profiles of the communities | Transcriptomic profiles of the communities assessed by meta-transcriptomics | 10 months | |
Primary | Metabolites produced and microbial metabolic pathways | Metabolites produced and microbial metabolic pathways will be assessed by global metabolomics | 10 months |
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