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Could rice formula be a safe alternative for kids allergic to Cow's milk?

NCT ID NCT07197814

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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)
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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 3 times

Summary

This study is testing whether a new formula made from hydrolyzed rice proteins is safe for infants and young children (1–36 months) with IgE-mediated cow's milk allergy. In a double-blind test, children will receive either the rice formula or a placebo, then be monitored for allergic reactions. If no reactions occur, they will drink the rice formula exclusively for 7 days at home. The goal is to see if this formula can be labeled hypoallergenic, offering a new option for families managing cow's milk allergy.

What this could mean

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

Active substance
hydrolyzed rice protein formula
What this could lead to
If successful, this could provide a safe, hypoallergenic formula option for children with cow's milk allergy, reducing reliance on more expensive or less palatable alternatives.
What could go wrong
This is a small early-stage trial (29 children) with no control for long-term safety. Some children may still react to the rice formula, and results may not apply to all allergic children.

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 29 people

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

Started

Jan 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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 36 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 and young children between 1 and 36 months of age * Consuming at least 240 ml/day of formula * Gestational age ≥ 37 weeks * Diagnosis of IgE-mediated CMA confirmed through a DBPCFC performed within 3 months prior to the enrolment * Stable clinical condition and free from any symptoms possibly related to CMA for at least ≥4 weeks prior to recruitment * Observing a strict cow's milk proteins elimination diet for at least 4 weeks prior to study enrollment * Parents or legal guardians agree not to enroll infant in another interventional clinical study while participating in this study * Written informed consent form obtained from both parents (or legally acceptable representative \[LAR\], if applicable) * Infant's parents / LAR are of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol. * Signed authorization obtained from both parents or legal guardian to use and/or disclose Protected Health Information for infant from birth through the length of the study period Exclusion Criteria: * Infant is exclusively breastfed. * Any chronic diseases, chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria). * Major gastrointestinal disease/abnormalities (other than CMA). * Other food allergies * Eosinophilic disorders of the gastrointestinal tract. * Evidence of non-IgE-mediated CMA. * Immunodeficiency. * Use of drugs that may interfere with the interpretation and safety of the SPT procedure planned on Inclusion visit such as antihistamines and topical corticosteroids in the previous week, angiotensin-converting enzyme (ACE) inhibitors within the 2 days before or beta-blockers the day before as well as skin moisturizers used on the skin where solution drops will be applied. * Previous use of systemic immunomodulatory treatment at any time before study entry. * Use of systemic antibiotics or anti-mycotic drugs within 4 weeks before study entry. * Persistent wheeze or chronic respiratory disease. * Severe uncontrolled eczema. * Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment. * Infant's parents/LAR have medical or psychiatric condition that, in the judgement of the Investigator, would make the subject inappropriate for entry into the study.

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Conditions

The condition(s) this trial relates to.

food allergy Milk Hypersensitivity

As listed by the trial registrant

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

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

  • Federico II, University of Naples, Department of Translational Medical Science

    RECRUITING

    Naples, Italy

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