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.
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
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
Crossover
Rice formula (New formula based on hydrolysed rice proteins)
Other interventionInfant formula based on hydrolysed rice proteins.
Placebo formula
Other interventionThe 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.
Hypoallergenicity of the Rice formula
It will be assessed through the absence of medically confirmed allergic reaction to the study formula (Rice formula), based on assessment of clinical signs and symptoms at clinical DBPCFC testing and during the 7-day open feeding period.
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Health and Happiness Research Limited
Lead sponsor
Federico II University
Collaborator
