Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins in Children With IgE-mediated Cow's Milk Allergy
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
• 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