MedTrace Logo

Impact of Breast Milk miRNAs on the Infant Gut Microbiota

NCT06651216 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-10-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Alexis MOSCA, MD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-05-01
Completion
2027-05-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06651216 on ClinicalTrials.gov