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

1 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

25

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Turquía (Türkiye)
      • Istanbul, Turquía (Türkiye)
        • Reclutamiento
        • Child Health and Diseases Clinic, Esencan Hospital
        • Contacto:
          • Özden Durmuş Gönültaş, MD
          • Número de teléfono: 905073121218
          • Correo electrónico: ozdengnlts@gmail.com
        • Sub-Investigador:
          • Özden Durmuş Gönültaş, MD
      • Istanbul, Turquía (Türkiye)
        • Reclutamiento
        • İstanbul University İstanbul Medical Faculty Department of Pediatrics Division of Social Pediatrics
        • Contacto:
        • Sub-Investigador:
          • Özden Durmuş Gönültaş, MD
        • Investigador principal:
          • Gonca Keskindemirci, Prof
        • Investigador principal:
          • Gülbin E Gökçay, Prof
        • Investigador principal:
          • Günnur Deniz, Prof
        • Investigador principal:
          • Asuman Gedikbaşı, Prof
        • Investigador principal:
          • Birsen Karaman, Prof
        • Investigador principal:
          • Bilge Ş Selçuk, Assoc Prof
        • Sub-Investigador:
          • Gizem Kara Elitok, Assoc Prof
        • Sub-Investigador:
          • Ebru Kılıç
        • Sub-Investigador:
          • Ayşenur Kökoğlu
        • Sub-Investigador:
          • Suzin Tatonyan

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Expression Levels of Treg-Associated miRNAs in Breast Milk
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Istanbul University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de octubre de 2025

Finalización primaria (Estimado)

30 de septiembre de 2026

Finalización del estudio (Estimado)

30 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

10 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de agosto de 2026

Publicado por primera vez (Actual)

4 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • TSA-2025-41296

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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