A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula (NCT04519827) | Clinical Trial Compass
CompletedNot Applicable
A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula
Italy, Spain39 participantsStarted 2020-05-21
Plain-language summary
Cow's Milk Allergy (CMA) affects between 2-3% of young children but its severity varies between regions/countries. While the long-term prognosis for CMA is good, with the majority (80-90%) of children outgrowing their allergy by around 3-5 years. Breast feeding is the most optimal form of feeding for all infants, regardless of their condition, and in those with CMA maternal dairy exclusion is recommended as first line treatment. In non-breast fed or mixed feeding, a hypoallergenic milk substitute is recommended for young infants. The AAP and other societies such as EAACI and ESPGHAN considers a formula to be 'hypoallergenic' if at least 90% of children with documented CMA tolerate it, with a 95% CI, under double-blind, placebo-controlled conditions.This equates to at least 29 children who should tolerate the product following blind and open challenge.
Who can participate
Age range10 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Children \<10 yrs of age
✓. Proven IgE-mediated CMA
✓. \>2500g at birth
✓. \> 37 weeks gestation
✓. Written informed consent provided by parent(s)/guardian
Exclusion criteria
✕. Infants/children with severe concurrent illness (other than food allergy/CMA)
✕. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
✕. Participation in other studies involving use of milk replacement products designed to treat/manage CMA within two weeks prior to entry into this study