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RECRUITING
NCT07744373

Tregs and miRNAs in Breast Milk: Effects on Infant Food Tolerance

Sponsor: Istanbul University

View on ClinicalTrials.gov

Summary

This prospective observational study aims to identify and characterize immunoregulatory microRNAs (miRNAs) associated with regulatory T cells (Tregs) in human breast milk and to evaluate their temporal expression patterns. Breast milk samples will be collected longitudinally, including colostrum, transitional milk (days 10-15), and mature milk at 1, 4, 6, and/or 9 months postpartum. The study will investigate miRNAs that may influence the development and function of Treg cells and assess changes in their expression over time. In addition, a single blood sample will be obtained from infants during routine clinical visits (6-9 months postpartum) to analyze Treg-related miRNAs and target genes and to evaluate their relationship with breast milk components. The study also aims to explore the association between breast milk miRNAs, Treg-related immune mechanisms, and the development of infant food tolerance.

Official title: Immunoregulatory Factors in Human Breast Milk: Relationship Between Regulatory T Cells (Tregs), miRNAs and Food Tolerance

Key Details

Gender

All

Age Range

0 Days - 9 Months

Study Type

OBSERVATIONAL

Enrollment

25

Start Date

2025-10-01

Completion Date

2026-09-30

Last Updated

2026-08-04

Healthy Volunteers

Yes

Locations (2)

Child Health and Diseases Clinic, Esencan Hospital

Istanbul, Turkey (Türkiye)

İstanbul University İstanbul Medical Faculty Department of Pediatrics Division of Social Pediatrics

Istanbul, Turkey (Türkiye)