Impact of Breast Milk miRNAs on the Infant Gut Microbiota (NCT06651216) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of Breast Milk miRNAs on the Infant Gut Microbiota
France200 participantsStarted 2024-11-01
Plain-language summary
The first 1000 days of life are a critical period for future health. A healthy gut microbiota (GM) is essential for preventing both short-term and long-term health issues. Breast milk (BM) plays a key role in establishing the GM, as, unlike formula milk, it contains miRNAs that may interact with and modulate the microbiota.
Primary Objective: To study the effect of BM on the composition of fecal miRNAs in exclusively breastfed infants compared to those fed with formula milk at different times (D10, D30, D60, M6, M12).
Secondary Objectives:
Analyze the effect of BM miRNAs on infant fecal microbiota, taking environmental confounding factors into account.
Study the influence of BM microbiota on miRNA profiles in the milk. Examine the effect of BM microbiota on the infants' gut microbiota. Explore the links between BM miRNAs, infant gut microbiota, and intestinal inflammation.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pregnant women in the 3rd trimester of pregnancy (3T) with a normal course of pregnancy up to 39 weeks consulting for the monitoring visit at the Robert-Debré hospital.
* Patients who did not receive antibiotic treatment or probiotics in 3T.
* Patient with a negative PV for Strepto B
* Patients who do not have complications such as pre-eclampsia or gestational diabetes.
* Breastfeeding (+/- milk pump) or exclusive artificial breastfeeding.
* No opposition from the mother
* Ability to master the French language required.
* Freezer at home.
* Affiliation to a social security scheme.
Exclusion Criteria:
* Cesarean delivery
* Perinatal pathologies (Anoxia, IUGR, etc.)
* Neonatal pathologies (FGR, malformations, etc.)
* Initial choice of mixed breastfeeding
* Patient under AME (State Medical Aid)Critères d'exclusions :
* Antibiotics for the mother or child before day 60
* Antifungal for the mother or child before day 60
* Complete cessation of breastfeeding before day 60
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Explore the effect of breast milk on the composition of fecal miRNAs in infants