Tregs and miRNAs in Breast Milk: See if breast milk miRNAs influence infant immune cells and food tolerance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective study will collect breast milk at several postnatal time points (colostrum, days 10-15, and months 1, 4, 6, and/or 9) and a single infant blood sample at 6-9 months to explore miRNAs associated with regulatory T cells. Researchers will analyze breast milk and infant blood for regulatory T cell–related miRNAs and their target genes, and will relate these findings to the infant’s food tolerance development. Laboratory work will include RNA isolation from milk, molecular analyses, and immunologic/cytometric assessments, performed under standardized sample handling. The study aims to identify temporal patterns of miRNA expression and potential links to immune regulation and food tolerance outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. Infants who are exclusively breastfed for the first 6 months.
3. 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).
4. Infants aged 0-9 months, born at term (≥37 weeks gestation) with no major congenital anomalies or chronic illnesses.
5. Mothers and infants who provide informed consent for participation in the study.

Exclusion Criteria:

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

Where it's running

• 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

Study contacts

• Study coordinator: Gonca Keskindemirci, MD, PhD
• Email: keskindemirci@hotmail.com
• Phone: 0905324934651

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.