Tregs and miRNAs in Breast Milk: Effects on Infant Food Tolerance | NCT07744373

NCT07744373

Overview

NCT ID: NCT07744373
Lead Sponsor: Istanbul UniversityOTHER
Official Title: Immunoregulatory Factors in Human Breast Milk: Relationship Between Regulatory T Cells (Tregs), miRNAs and Food Tolerance
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

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Central Contacts: Gonca Keskindemirci, MD, PhDContact
keskindemirci@hotmail.com

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