Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota (EPROMED)

Larena SAS

Status

Terminated

Conditions

Dysbiosis

Treatments

Other: Stool sampling

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06114303

PIL-RIPH3-EPROMED-023

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

Female

Ages

1 to 40 years old

Volunteers

Accepts Healthy Volunteers

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