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Could tiny molecules in breast milk shape a Baby's food tolerance?

NCT ID NCT07744373

Knowledge-focused Sponsor: Istanbul University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This study looks at whether tiny molecules called microRNAs in breast milk are linked to how well a baby's immune system tolerates food. Researchers will collect breast milk samples at several stages—from early colostrum to mature milk—and also take a small blood sample from infants around 6–9 months old. The goal is to see if these microRNAs relate to regulatory T cells and whether they might influence the development of food tolerance in babies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If certain microRNAs in breast milk are linked to infant food tolerance, this could point toward ways to support allergy prevention or early dietary guidance.
What could go wrong
This is a small observational study, so it can only reveal associations, not cause and effect. Findings may not apply broadly beyond the specific group studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

0 days to 9 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Food tolerance Immune tolerance

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Child Health and Diseases Clinic, Esencan Hospital

    RECRUITING

    Istanbul, Turkey (Türkiye)

  • İstanbul University İstanbul Medical Faculty Department of Pediatrics Division of Social Pediatrics

    RECRUITING

    Istanbul, Turkey (Türkiye)

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