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

NCT07744373 | Recruiting

• 1 other identifier: TSA-2025-41296
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Immune Tolerance; Food Tolerance

Keywords

Food Tolerance; breast milk; Immune Tolerance

Outcome Measures

Primary Outcomes (1)

• Expression Levels of Treg-Associated miRNAs in Breast Milk

  Quantitative analysis of regulatory T cell (Treg)-associated microRNA (miRNA) expression levels in breast milk samples.

  Colostrum (day 0-7), days 10-15 (transitional milk), and at 1, 4, 6, and 9 months postpartum

Eligibility Criteria

• Age: 0 Days - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This study will include healthy lactating mothers and their term infants (≥37 weeks gestation) who are followed at Istanbul University, Istanbul Medical Faculty, Department of Social Pediatrics, Well Child Outpatient Clinic or the Esencan Hospital Outpatient Clinic. Infants must be exclusively breastfed for the first 6 months. Mothers and infants must be willing to provide breast milk and infant blood samples at specified time points and provide informed consent. Infants with chronic illnesses or major congenital anomalies, and mothers unable or unwilling to comply with study procedures, will be excluded.

You may qualify if:

• Lactating mothers and their infants attending the Child Health and Diseases Clinic at Istanbul University Faculty of Medicine, or the Child Health and Diseases Clinic at Esencan Hospital.
• Infants who are exclusively breastfed for the first 6 months.
• Mothers willing to provide breast milk samples at multiple time points (colostrum, transitional milk, and mature milk at 1, 4, 6, and/or 9 months postpartum).
• Infants aged 0-9 months, born at term (≥37 weeks gestation) with no major congenital anomalies or chronic illnesses.
• Mothers and infants who provide informed consent for participation in the study.

You may not qualify if:

• Infants who are not exclusively breastfed for the first 6 months.
• Infants with chronic illnesses or diagnosed immunodeficiency, metabolic, or gastrointestinal disorders.
• Mothers who are unable or unwilling to provide informed consent.
• Mothers with chronic illnesses or immunological disorders that may affect breast milk composition.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (2)

Child Health and Diseases Clinic, Esencan Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

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

Istanbul, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Gonca Keskindemirci, MD, PhD

CONTACT

0905324934651; keskindemirci@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: August 4, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-08

Locations

TU (2)