Clinical trial NCT06114303: Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota
Official 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dysbiosis
Lead sponsor: Larena SAS
Sponsor class: INDUSTRY
Collaborators: name: Université Paris-Saclay
First posted: 2023-11-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The mother/daughter " duos " participating in the study will be drawn from a panel of volunteers.

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.


Eligibility 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,
* 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

Primary outcomes:
measure: Transcriptional activity of microbiomes
timeFrame: 10 months
measure: Transcriptomic profiles of the communities
timeFrame: 10 months
measure: Metabolites produced and microbial metabolic pathways
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: