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Rice formula could be a safe alternative for Milk-Allergic babies

NCT ID NCT06288503

Disease control Sponsor: Nutricia UK Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a hydrolysed rice formula to a standard cow's milk-based formula in 86 infants aged 0-13 months with cow's milk allergy. Over 28 days, researchers will measure growth, digestive comfort, and allergy symptoms to see if the rice formula works just as well. If successful, it could provide another feeding option for families managing this common allergy.

What this could mean

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

Active substance
hydrolysed rice protein formula
What this could lead to
If it works, this could offer a safe, effective alternative to cow's milk-based formulas for infants with cow's milk allergy.
What could go wrong
This is a small, early-stage trial (86 infants) comparing two formulas, not a cure. Results may not apply to all infants, and some may still react to the rice 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 86 people

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

Started

Feb 2024

Expected to finish

Jul 2027

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

0 to 13 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: * Male or female * Aged 0-13 months * Presenting to primary or secondary care with symptoms/clinical history suggestive of CMA * Will receive at least 30% of energy requirements from the study formula * Written informed consent from parent/carer Exclusion Criteria: * Severe CMA (including anaphylaxis) and/or requiring an AAF * Faltering growth (based on NICE guidelines36 - Appendix 1) * Previous allergy to any study product ingredients (including whey hydrolysate and/or rice) * Primary lactose intolerance * Food Protein-Induced Enterocolitis Syndrome (FPIES) * Exclusively breast fed * Severe concurrent or chronic disease or genetic syndrome that may impact growth or other outcomes * Severe hepatic or renal insufficiency * Premature infants (born \<37 weeks) with a corrected age of \<4 weeks * Requirement for any parenteral nutrition * Participation in other clinical intervention studies within 1 month of recruitment * Concern around the willingness/ability of the caregiver to comply with the study protocol and/or study requirements

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • Bristol Royal Hospital for Children

    RECRUITING

    Bristol, Somerset, BS16 1TA, United Kingdom

  • Gloucestershire Royal NHS Trust

    RECRUITING

    Gloucester, Gloucestershire, GL1 3NN, United Kingdom

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