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New rice formula offers hope for Milk-Allergic infants

NCT ID NCT06633289

Symptom relief Sponsor: Société des Produits Nestlé (SPN) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a new formula made from hydrolyzed rice protein is safe for infants and young children with cow's milk protein allergy. 43 children with confirmed IgE-mediated allergy were given the formula in a controlled food challenge. The goal was to see if they could drink it without having an allergic reaction.

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

43 people

The number who actually took part.

Started

Nov 2024

Finished

Apr 2026

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

60 days to 3 years

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. Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\]), if applicable) 2. Child gestational age ≥ 37 completed weeks 3. Child aged ≥ 60 days and less than 36 months at enrollment 4. Documented IgE-mediated CMPA no more than 6 months prior to enrollment 5. Child is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study 6. Child's parent(s) and LAR (if applicable) is 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 Exclusion criteria: 1. Child is exclusively breastfed 2. Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies 3. Congenital heart disease or treatment by B-blockers 4. Major gastrointestinal disease / abnormalities (other than CMPA) 5. Known or suspected soy allergy 6. Glucose-galactose malabsorption 7. Immunodeficiency 8. Children who are unable to discontinue antihistamine use (excluding eye drops) within 7 days prior to a food challenge and oral steroid use within 14 days prior to enrollment 9. Persistent wheeze or chronic respiratory disease 10. Severe uncontrolled eczema or urticaria 11. Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome), or allergy to any ingredient in the formulas 12. Child's parent has other medical or psychiatric condition that, in the judgement of the Investigator, would make the child inappropriate for entry into the study 13. Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment 14. Child's parents have not reached legal age of majority (18 years).

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Conditions

The condition(s) this trial relates to.

Heiner syndrome Milk Hypersensitivity

As listed by the trial registrant

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

Cow's milk protein allergy

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria di Parma, Italy

    Parma, Italy

  • BioMedical Centers sp. z o.o.

    Warsaw, 02-595, Poland

  • Centrum Medyczne Plejady

    Krakow, Poland

  • Charité - Universitätsmedizin Berlin Klinik für Pädiatrie m.S. Pneumologie/Immunologie

    Berlin, Germany

  • IRCCS Azienda Ospedaliero Universitaria Meyer Viale Gaetano Pieraccini

    Florence, Italy

  • Jagiellonian University Medical College

    Krakow, Poland

  • Nicolaus Copernicus University in Torun

    Bydgoszcz, Poland

  • Ospedale dei Bambini V. Buzzi Via Castelvetro, 32

    Milan, 20154, Italy

  • Pediatrics Department at the Medical University of Warsaw

    Warsaw, Poland

  • Universiy of Naples Federico II

    Naples, Italy

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika

    Lodz, Poland

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