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Milk-Free diet may boost gut defenses in allergic infants

NCT ID NCT07242950

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 34 breastfed infants under 6 months old with cow's milk protein allergy. Researchers wanted to see if a cow's milk elimination diet for mothers and babies could improve symptoms, growth, and gut immune markers like MUC2 and sIgA. They collected stool samples and tracked symptoms over time. The study is complete and observational, meaning it observes effects without testing a new drug.

What this could mean

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

Active substance
cow's milk protein elimination diet
What this could lead to
If successful, this could help doctors understand how diet changes improve gut health and symptoms in infants with cow's milk allergy.
What could go wrong
This is a small, completed observational study with only 34 infants, so results may not apply to all babies. It does not test a new treatment.

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

34 people

The number who actually took part.

Started

Sep 2023

Finished

Aug 2024

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

The study included breastfed babies under 26 weeks of age who were diagnosed with new non-IgE-mediated CMPA by an allergist, had an elimination diet, and applied to two hospitals designated in Türkiye. Infants and their mothers without allergies or atopic diseases, similar in age and gender, were in the control group.

Ages

1 week to 26 weeks

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 for the case group: * Diagnosed with non-IgE-mediated ARI during the study period, * Aged less than 26 weeks at the beginning of the study, * Still breastfeeding, * Gestational age between 37 and 42 weeks, * Single birth, * Birth weight ≥ 2500 g and ≤ 4500 g, and their mothers. The exclusion criteria for the case group are as follows: those with a diagnosed chronic or systemic disease, those with neonatal disease or congenital malformation, those who have had an infection or illness requiring hospitalisation during the study period, infants who have never been breastfed and their mothers. Inclusion criteria for the control group: * Age less than 26 weeks at the beginning of the study, * No allergy to food or medication, * No diagnosis of an atopic disease, * Still breastfeeding, * Gestational age between 37 and 42 weeks, * Single birth, * Infants with birth weight ≥ 2500 g and ≤ 4500 g and their mothers. The exclusion criteria for the control group are as follows: Those with a diagnosed allergy or atopic disease, those with a diagnosed known chronic or systemic disease, those with neonatal disease or congenital malformations, those who have experienced an infection or illness requiring hospitalisation during the study period, infants who have never received breast milk and their mothers.

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Conditions

The condition(s) this trial relates to.

autosomal dominant medullary cystic kidney disease with or without hyperuricemia food protein-induced enterocolitis syndrome Heiner syndrome

As listed by the trial registrant

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

Cow milk protein allergy Diet therapy Immunoglobulin A MUCIN

Contacts and locations

Locations

  • Baskent University

    Ankara, Etimesgut, 06790, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.