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Special formula may help diagnose milk allergy vs intolerance in infants

NCT ID NCT07687797

Diagnosis Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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)
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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests whether a partially digested whey formula can help doctors tell the difference between a non-allergic milk intolerance and a true cow's milk protein allergy in babies. Infants aged 1 to 6 months with digestive symptoms will receive the special formula. The goal is to see how many actually have intolerance rather than allergy, which could lead to better diagnosis and treatment.

What this could mean

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

Active substance
partially hydrolysed whey based formula
What this could lead to
If successful, this approach could help doctors quickly tell whether a baby has a milk allergy or a less severe milk intolerance, avoiding unnecessary treatments.
What could go wrong
This is a small, early-stage study. The special formula may not clearly separate the two conditions, and results may not apply to all infants.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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.

Ages

1 month to 6 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * 1-6 months of age * formula fed infants * CoMiSS score above 10 * Repeated body mucoid stool Exclusion Criteria: * IgE mediated disease * Skin allergy * Respiratory symptoms * Exclusive or mixed breast feeding

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Conditions

The condition(s) this trial relates to.

food protein-induced allergic proctocolitis Heiner syndrome

As listed by the trial registrant

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

Cow milk intolerance Cow milk protein allergy

How to take part

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

  1. The places running it

    1 site. 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

  • Faculty of Medicine Ain Shams University

    Cairo, 11566, Egypt

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