Actively Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
Led by Health and Happiness Research Limited · Updated on 2026-01-29
29
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
Sponsors
H
Health and Happiness Research Limited
Lead Sponsor
F
Federico II University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to see if a new formula based on hydrolysed rice proteins (Rice formula) is well tolerated by infants and young children with cow's milk allergy. In case the Rice formula is well tolerated, the formula will be considered " hypoallergenic ". The main question it aims to answer is: Does the Rice formula cause allergic reactions in infants and young children who are allergic to cow's milk? Researchers will compare during a double-blind placebo-controlled food challenge (DBPCFC) the Rice formula to a Placebo formula to see if any allergic symptom appears after feeding with the Rice formula. If children do not show any allergic symptoms during the DBPCFC, they will then be exclusively formula-fed the Rice formula for 7 days. Participants will: * come at the hospital twice (around 7 days apart) for the DBPCFC * then, after this procedure, be fed the Rice formula for 7 days, as a replacement for their usual infant formula Their parents will pay attention to the appearance of any allergic symptom after each day of the DBPCFC, and during the 7-day feeding period. They will keep a diary of any adverse event in their child, the use of any concomitant treatment, and the introduction in their child's diet of any new allergenic food. In addition, during the 7-day feeding period, they will report quantities of the Rice formula consumed, data on regurgitations/vomiting if any, stool consistency/frequency/colour and their satisfaction.
CONDITIONS
Official Title
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants and young children between 1 and 36 months of age
- Consuming at least 240 ml/day of formula
- Gestational age at birth of 37 weeks or more
- Diagnosis of IgE-mediated cow's milk allergy confirmed by a double-blind placebo-controlled food challenge within 3 months before enrollment
- Stable health condition with no symptoms related to cow's milk allergy for at least 4 weeks before recruitment
- Following a strict cow's milk protein elimination diet for at least 4 weeks before study enrollment
- Parents or legal guardians agree not to enroll the child in another interventional clinical study during this study
- Written informed consent obtained from both parents or legal guardians
- Parents or legal guardians are adults with parental authority, understand the study documents, and can meet study requirements
- Signed permission from both parents or legal guardians to use or share the child's protected health information during the study period
You will not qualify if you...
- Infant is exclusively breastfed
- Presence of any chronic diseases, chromosomal abnormalities, or major congenital anomalies
- Major gastrointestinal diseases or abnormalities other than cow's milk allergy
- Presence of other food allergies
- Eosinophilic disorders of the gastrointestinal tract
- Evidence of non-IgE-mediated cow's milk allergy
- Immunodeficiency
- Use of antihistamines, topical corticosteroids, ACE inhibitors, beta-blockers, or skin moisturizers at sites of skin testing within specified time frames before study entry
- Previous use of systemic immunomodulatory treatments at any time before study entry
- Use of systemic antibiotics or antifungal drugs within 4 weeks before study entry
- Persistent wheezing or chronic respiratory disease
- Severe uncontrolled eczema
- Participation in another interventional clinical study within 4 weeks before enrollment
- Parents or legal guardians have medical or psychiatric conditions that make participation inappropriate in the investigator's judgment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Federico II, University of Naples, Department of Translational Medical Science
Naples, Italy
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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