Tolerance of a hydrolyzed rice-protein baby formula in children with cow's milk allergy.
Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins in Children With IgE-mediated Cow's Milk Allergy
This will test whether a new hydrolyzed rice-protein formula causes allergic reactions in infants and young children (1–36 months) with IgE-mediated cow's milk allergy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 1 Month to 36 Months |
| Sex | All |
| Sponsor | Health and Happiness Research Limited Industry-sponsored |
| Locations | 1 site (Naples) |
| Trial ID | NCT07197814 on ClinicalTrials.gov |
What this trial studies
Researchers will perform a double-blind, placebo-controlled food challenge (DBPCFC) comparing the hydrolyzed rice-protein formula to a placebo formula during two hospital visits about seven days apart. If no allergic symptoms occur during the DBPCFC, enrolled children will then be exclusively fed the rice formula at home for seven days while parents monitor for reactions. Eligible participants are infants 1–36 months with a prior DBPCFC confirming IgE-mediated cow's milk allergy, on a strict milk-elimination diet and clinically stable. The main outcome is whether allergic symptoms appear after feeding the rice formula, with the product considered hypoallergenic if tolerated.
Who should consider this trial
Good fit: Infants and young children aged 1–36 months with confirmed IgE-mediated cow's milk allergy, consuming at least 240 ml/day of formula, clinically stable and on a cow's milk protein elimination diet are the intended participants.
Not a fit: Children with non–IgE-mediated milk allergy, recent or unstable allergic symptoms, prematurity (<37 weeks gestation), or those outside the 1–36 month age range are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If tolerated, the formula could become an additional hypoallergenic milk-free feeding option for infants with IgE-mediated cow's milk allergy.
How similar studies have performed: Previous smaller studies and clinical reports indicate hydrolyzed rice-protein formulas are often tolerated by infants with cow's milk allergy, though evidence is less extensive than for extensively hydrolyzed cow formulas or amino acid formulas.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Naples
- Federico II, University of Naples, Department of Translational Medical Science — Naples, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.