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

NCT07744373 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2026-08-04

No results posted yet for this study

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

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Eligibility

Min Age
0 Days
Max Age
9 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT07744373 on ClinicalTrials.gov