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New study to check if special formula helps allergic babies grow well

NCT ID NCT07174999

Knowledge-focused Sponsor: Assiut 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study will observe 160 infants aged 1 to 12 months who have cow's milk protein allergy and are fed an amino acid-based formula. Researchers will measure weight, length, and head growth over time to see if the formula supports healthy development. The goal is to gather information, not to test a new treatment.

What this could mean

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

Active substance
amino acid-based formula
What this could lead to
If successful, this could provide better understanding of how well amino acid-based formula supports growth in infants with cow's milk allergy.
What could go wrong
This is an observational study, not a treatment trial. It will not test a new therapy or change current care. 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.

Participants

About 160 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

The study population will include infants aged 1 to 12 months who are exclusively or predominantly receiving amino acid-based formula (AAF) as part of their routine medical care due to established clinical indications.

Ages

1 month to 12 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. Infants aged 1 to 12 months at the time of enrollment. 2. Infants who are exclusevel or predominantly fed amino acid-based formula (AAF) in addition to elimination diet for at least 12 consecutive weeks. 3. Infants who are diagnosed as CMPA by CoMiSS score ≥ 10 and confirmed by OFC test. 4. Infants with informed parental or guardian consent to participate in the study. Exclusion Criteria: * 1- Infants with congenital anomalies or syndromes affecting growth and development (e.g., trisomy 21, major cardiac defects). 2- Infants with chronic systemic illnesses unrelated to feeding (e.g., cystic fibrosis, chronic kidney disease). 3- Infants receiving additional specialized nutrition support (e.g., parenteral nutrition or tube feeding not involving AAF). 4- Infants with incomplete or insufficient medical records at the time of assessment.5- Infants who have been on AAF for less than 4 weeks or whose feeding regimen is not stable. 6- Infants whose parents or legal guardians decline or withdraw informed consent.

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Conditions

The condition(s) this trial relates to.

Heiner syndrome

As listed by the trial registrant

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

Cow's milk protein allergy protein intolerance failure to thrive

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

  • Assiut University

    Asyut, Egypt

More trials for these conditions

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