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New rice formula could help babies with milk allergy grow and thrive

NCT ID NCT06633250

Disease control 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tests a new formula made from hydrolyzed rice protein in 104 infants up to 8 months old with cow's milk protein allergy. The goal is to see if it supports normal growth, digestion, and quality of life as well as a standard cow's milk-based formula. Infants will receive either the rice formula or the control formula for 4 months, with regular check-ups on weight, length, and symptoms.

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, well-tolerated alternative formula for infants with cow's milk allergy, supporting normal growth and easing digestive symptoms.
What could go wrong
This is a relatively small, early-stage study (104 infants) comparing to an existing formula, so results may not apply broadly. The rice formula might not match the control in growth or tolerance.

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 104 people

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

Started

Oct 2024

Expected to finish

Aug 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

Up to 8 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. Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\]), if applicable) 2. Infant gestational age ≥ 37 completed weeks 3. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg 4. Singleton birth 5. Infant age ≤ 8 months 6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk 7. Suspected CMPA as per standard clinical practice and in conjunction with at least 2 symptoms present from the list shown below: 1. Inconsolable crying, regurgitation, liquid stools or constipation, skin atopic lesion, cow's milk provoked temporary urticaria/angioedema or vomiting, bloody streaks in stool, or respiratory symptoms 2. For diagnosis based on either a positive IgE blood test, skin prick test or food challenge, only at least 1 symptom from above list needs to be present 8. Infant is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study 9. Infant's parent(s)/LAR is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol Exclusion Criteria: 1. History of intolerance to eHF formula 2. Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria) 3. Major gastrointestinal disease / abnormalities (other than CMPA) 4. Known or suspected lactose intolerance or malabsorption 5. Known or suspected soy allergy 6. Glucose-galactose malabsorption 7. Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome). 8. Immunodeficiency 9. Persistent wheeze or chronic respiratory disease 10. Severe uncontrolled eczema 11. History of severe anaphylactic reaction (e.g., requiring ≥ 2 doses of epinephrine) to cow's milk or breast milk at any time prior to enrollment 12. Weight-for-age value \< -2 or \> 2 standard deviations from the WHO Child Growth Standards median at enrollment 13. Height-for-age \< -2 or \> 2 standard deviations from the WHO Child Growth Standards median at enrollment 14. Infant's parent has other medical or psychiatric condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study 15. Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment

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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 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

    16 sites in 3 countries. 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

  • AO Ordine Mauriziano

    RECRUITING

    Turin, Italy

  • AOUP Ospedale Santa Chiara

    COMPLETED

    Pisa, Italy

  • Alergo-Med Specjalistyczna Przychodnia Lekarska

    RECRUITING

    Tarnów, Poland

  • Azienda Ospedaliera Universitaria Federico II

    RECRUITING

    Naples, Italy

  • Azienda Ospedaliero Universitaria di Parma

    RECRUITING

    Parma, Italy

  • BioMedical Centers

    RECRUITING

    Janki, Poland

  • Centrum Medyczne Plejady

    COMPLETED

    Krakow, Poland

  • Centrum Medyczne Pratia

    RECRUITING

    Bydgoszcz, Poland

  • Charité Universitätsmedizin Berlin

    RECRUITING

    Berlin, Germany

  • ETG Lublin

    RECRUITING

    Lublin, Poland

  • IN-VIVO Bydgoszcz

    RECRUITING

    Bydgoszcz, Poland

  • Jagiellonian University Medical College

    RECRUITING

    Krakow, Poland

  • Korczowski Bartosz Gabinet Lekarski

    RECRUITING

    Rzeszów, Poland

  • Ospedale Pediatrico Bambino Gesu

    NOT_YET_RECRUITING

    Rome, Italy

  • Poliklinika Ginekologiczno-Położnicza Arciszewscy

    RECRUITING

    Bialystok, Poland

  • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

    RECRUITING

    Bydgoszcz, Poland

  • University Hospital of Warsaw

    COMPLETED

    Warsaw, Poland

  • Vitamed Galaj i Cichomski

    RECRUITING

    Bydgoszcz, Poland

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika

    RECRUITING

    Lodz, Poland

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