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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06114303
Other study ID # PIL-RIPH3-EPROMED-023
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 20, 2025
Est. completion date May 31, 2025

Study information

Verified date February 2023
Source Larena SAS
Contact Quentin DAUCHET
Phone +33144388838
Email q.dauchet@pileje.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Stool sampling
1 stool sample is taken during the study with a stool sample kit

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Larena SAS Université Paris-Saclay

Outcome

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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