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Which formula works best for Milk-Allergic babies? new study aims to find out

NCT ID NCT07199023

Symptom relief Sponsor: Ruijin Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This study tests two special formulas—amino acid formula (AAF) and extensively hydrolyzed formula (eHF)—in 360 infants aged 0-6 months with suspected cow's milk protein allergy. Babies will receive one formula for at least 2 weeks, and doctors will check if symptoms like diarrhea and skin issues improve. The goal is to find which formula works faster and better, and to create a screening tool for Chinese infants.

What this could mean

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

Active substance
hypoallergenic formulas (amino acid formula and extensively hydrolyzed formula)
What this could lead to
If successful, this study could help doctors choose the best formula to quickly relieve symptoms in infants with cow's milk protein allergy.
What could go wrong
This is an early-stage study with no phase, and results may not apply to all infants. Some infants may not improve on either formula.

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 360 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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

0 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: * Infants aged 0-6 months; * Diagnosed with suspected CMPA at the time of presentation; * Artificially or mixed-feeding; * Parents willing to sign a written informed consent and comply with the study - protocol. Exclusion Criteria: * Infants currently receiving eHF or AAF formula; * Mixed-feeding infants whose current daily formula intake is less than 50% of their total milk intake or less than 200 ml; * Infants who have already started adding complementary foods; * Infants who have experienced severe food allergy symptoms such as shock, severe vomiting, etc. after taking cow's milk protein; * Infants with clinical manifestations of systemic allergic reaction or respiratory difficulties such as acute laryngeal edema or bronchial obstruction; * Infants who have used prednisolone or anti-allergic drugs in the past 2 weeks; * Infants with contraindications to eHF or AAF formula; * Infants whose parents are unable to fully report the occurrence of possible symptoms (e.g., insufficient language skills); * Infants with other serious diseases, including but not limited to growth retardation, metabolic disorders, kidney disease, congenital heart disease, medical conditions requiring hospitalization for more than 2 weeks, etc.; * Infants whose mothers are unable to avoid necessary foods when mixed-feeding.

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Conditions

The condition(s) this trial relates to.

food protein-induced allergic proctocolitis Heiner syndrome Milk Hypersensitivity

As listed by the trial registrant

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

Cow 39 S milk protein allergy Cow's milk protein allergy

How to take part

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  1. The official record

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  2. A doctor treating you

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