Could rice formula be a safe alternative for kids allergic to Cow's milk?
NCT ID NCT07197814
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
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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
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About 29 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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1 month to 36 months
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Federico II, University of Naples, Department of Translational Medical Science
RECRUITINGNaples, Italy
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