Tregs and miRNAs in Breast Milk: Effects on Infant Food Tolerance
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-9
SponsorIstanbul University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
Colostrum (day 0-7), days 10-15 (transitional milk), and at 1, 4, 6, and 9 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov