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

1. august 2026 opdateret af: Gonca Keskindemirci, Istanbul University

Immunoregulatory Factors in Human Breast Milk: Relationship Between Regulatory T Cells (Tregs), miRNAs and Food Tolerance

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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

Breast milk contains microRNAs (miRNAs) that contribute to the maturation of the infant immune system by influencing immune cell development, inflammatory mediator secretion, and maintenance of immunological homeostasis. Certain miRNAs, such as miR-92 and miR-17, play a role in B- and T-cell maturation, while miRNA-10a is associated with regulatory T cells (Tregs), which can modulate food allergic responses. This study aims to identify immunoregulatory Treg-associated miRNAs in breast milk, particularly those involved in the development and function of Treg cells; to analyze their expression in colostrum, transitional milk, and mature breast milk; to investigate their effects on Treg cells; and to examine the relationship between food tolerance and miRNA-Treg interactions.

Laboratory analyses will be conducted on maternal breast milk and infant blood samples. Breast milk samples will be manually expressed between 09:00 and 14:00 into sterile collection containers, with 7-10 mL collected per session. Five milliliters of each sample will be transferred into Eppendorf tubes and transported on ice within 30 minutes for molecular analysis. Each sample will be aliquoted into sterile 2 mL cryotubes, flash-frozen, and stored at -80°C until RNA isolation. The remaining 2-5 mL of each breast milk sample will be transported on ice within 30 minutes for immunologic and cytometric analyses. Infant blood samples obtained during routine follow-up visits will be analyzed for Treg-associated miRNAs and their target gene expression to evaluate correlations with maternal breast milk miRNA profiles and infant immune tolerance.

All laboratory analyses will be conducted using standard equipment and procedures in certified Genetics and Immunology laboratories. Through this approach, the study will examine longitudinal changes in Treg-associated miRNAs in breast milk, their correlation with infant immune parameters, and their potential role in promoting immune tolerance and preventing food allergy development. The results are expected to provide insights into early-life immune programming and may inform novel therapeutic interventions and preventive strategies.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

25

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
      • Istanbul, Tyrkiet (Türkiye)
        • Rekruttering
        • Child Health and Diseases Clinic, Esencan Hospital
        • Kontakt:
        • Underforsker:
          • Özden Durmuş Gönültaş, MD
      • Istanbul, Tyrkiet (Türkiye)
        • Rekruttering
        • İstanbul University İstanbul Medical Faculty Department of Pediatrics Division of Social Pediatrics
        • Kontakt:
        • Underforsker:
          • Özden Durmuş Gönültaş, MD
        • Ledende efterforsker:
          • Gonca Keskindemirci, Prof
        • Ledende efterforsker:
          • Gülbin E Gökçay, Prof
        • Ledende efterforsker:
          • Günnur Deniz, Prof
        • Ledende efterforsker:
          • Asuman Gedikbaşı, Prof
        • Ledende efterforsker:
          • Birsen Karaman, Prof
        • Ledende efterforsker:
          • Bilge Ş Selçuk, Assoc Prof
        • Underforsker:
          • Gizem Kara Elitok, Assoc Prof
        • Underforsker:
          • Ebru Kılıç
        • Underforsker:
          • Ayşenur Kökoğlu
        • Underforsker:
          • Suzin Tatonyan

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Expression Levels of Treg-Associated miRNAs in Breast Milk
Tidsramme: Colostrum (day 0-7), days 10-15 (transitional milk), and at 1, 4, 6, and 9 months postpartum
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2025

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

30. september 2026

Datoer for studieregistrering

Først indsendt

10. juli 2026

Først indsendt, der opfyldte QC-kriterier

1. august 2026

Først opslået (Faktiske)

4. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • TSA-2025-41296

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner