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NOT YET RECRUITING
NCT06651216

Impact of Breast Milk miRNAs on the Infant Gut Microbiota

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2024-11-01

Completion Date

2027-05-31

Last Updated

2024-10-21

Healthy Volunteers

Yes

Interventions

OTHER

Stool analysis

Analysis of infant fecal microbiota

OTHER

breast milk analysis

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

Locations (1)

Robert Debre Hospital Assistance Publique Hôpitaux de Paris

Paris, France