Impact of Breast Milk miRNAs on the Infant Gut Microbiota

NCT06651216 | Not Yet Recruiting

• 2 other identifiers: APHP240711IDRCB: 2024-A01059-38
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Milk; Stools

Outcome Measures

Primary Outcomes (1)

• Explore the effect of breast milk on the composition of fecal miRNAs in infants

  profiles and quantities of miRNAs at different times (D10, D30, D60, M6, and M12) in the stools of exclusively breastfed infants compared to those fed with formula milk

  12 months

Study Arms (2)

Breast feeding

Exclusively breastfed infants for 2 months

Other: Stool analysis; Other: breast milk analysis

Non breast feeding

Infants exclusively fed with formula milk

Other: Stool analysis

Interventions

Stool analysis OTHER

Analysis of infant fecal microbiota

Breast feeding; Non breast feeding

breast milk analysis OTHER

Analysis of the effect of breast milk miRNAs on infant fecal microbiota

Breast feeding

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Mother-child dyad in good health from birth

You may qualify if:

• 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.

You may not qualify if:

• Cesarean delivery
• Perinatal pathologies (Anoxia, IUGR, etc.)
• Neonatal pathologies (FGR, malformations, etc.)
• Initial choice of mixed breastfeeding
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Robert Debre Hospital Assistance Publique Hôpitaux de Paris

Paris, 75019, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool and breast milk

MeSH Terms

Interventions

Occult Blood

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Alexis MOSCA, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis MOSCA, MD

CONTACT

0187891646; alexis.mosca@aphp.fr

Servane ALIROL-BECHON, PhD

CONTACT

01.87.89.16.46; servane.alirol-bechon@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: November 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: October 21, 2024

Record last verified: 2024-10

Locations

FR (1)