Immune ToleranceNCT07744373
Tregs and miRNAs in Breast Milk: Effects on Infant Food Tolerance
An observational study of Immune Tolerance and Food Tolerance, run by Istanbul University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Immune Tolerance, Food Tolerance
- How many people
- 25 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Study 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.
Who may be able to join
- 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.
- Mothers and infants who provide informed consent for participation in the study.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Child Health and Diseases Clinic, Esencan Hospital
Istanbul
Özden Durmuş Gönültaş, MD, 905073121218, ozdengnlts@gmail.com
Özden Durmuş Gönültaş, MD
- Recruiting
İstanbul University İstanbul Medical Faculty Department of Pediatrics Division of Social Pediatrics
Istanbul
Gonca Keskindemirci, MD, PhD, 0905324934651, keskindemirci@hotmail.com
Gonca Keskindemirci, Prof
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Immune Tolerance, Food Tolerance
- Keywords
- Food Tolerance, breast milk, Immune Tolerance
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Colostrum (day 0-7), days 10-15 (transitional milk), and at 1, 4, 6, and 9 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ToleranceStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Keskindemirci, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744373
- Sponsor's protocol ID
- TSA-2025-41296
- Status last verified
- Aug 2026
- First submitted
- 10 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoregulatory Factors in Human Breast Milk: Relationship Between Regulatory T Cells (Tregs), miRNAs and Food Tolerance
- ClinicalTrials.gov ID
- NCT07744373
- Acronym / sponsor ID
- TSA-2025-41296
- Conditions
- Immune Tolerance, Food Tolerance
- Keywords
- Food Tolerance, breast milk, Immune Tolerance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 days to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study 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.
Key inclusion criteria (5 listed)
- 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.
- Mothers and infants who provide informed consent for participation in the study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expression Levels of Treg-Associated miRNAs in Breast Milk
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Tolerance and Food Tolerance, run by Istanbul University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gonca Keskindemirci, MD, PhD (0905324934651, keskindemirci@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression Levels of Treg-Associated miRNAs in Breast Milk (time frame: Colostrum (day 0-7), days 10-15 (transitional milk), and at 1, 4, 6, and 9 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.