Impact of Breast Milk miRNAs on the Infant Gut Microbiota
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Cesarean delivery
Perinatal pathologies (Anoxia, IUGR, etc.)
Neonatal pathologies (FGR, malformations, etc.)
Initial choice of mixed breastfeeding
Trial design
Treatments tested in this trial
- Stool analysis
- breast milk analysis
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Source ClinicalTrials.gov