Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-24 @ 7:15 PM
NCT ID:
NCT06114303
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
1 Year
Maximum Age:
40 Years
Study:
NCT06114303
Study Brief:
Protocol Section:
NCT06114303