Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rice formula (New formula based on hydrolysed rice proteins), Placebo formula.
- Who it may be relevant to
- Registry conditions: IgE-Mediated Cow Milk Allergy. Basic parameters: 1 months — 36 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins in Children With IgE-mediated Cow's Milk Allergy
Overview
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.
Interventions
- Other Rice formula (New formula based on hydrolysed rice proteins)
Infant formula based on hydrolysed rice proteins. - Other Placebo formula
The placebo formula will be the formula the subject is currently successfully fed with as part of his/her diet to eliminate cow's milk proteins.
Primary outcome measures
- Hypoallergenicity of the Rice formula [Time frame: At the end of the 7-day open feeding period]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
Italy · 1 center
- Federico II, University of Naples, Department of Translational Medical Science — Naples
Identifiers
NCT: NCT07197814 · BST-001