Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

A prospective, multi-centre double blind randomised placebo-controlled study to demonstrate the safety and tolerance of a new rice-based hydrolysate in children with diagnosed Cow's Milk Allergy (CMA). The test product being a new milk substitute hydrolysed rice-based formula with new ingredient. The results will satisfy the safety requirement when tolerated by 90% of children with proven CMA, with a confidence of 95%. New, and previously diagnosed children with confirmed CMA who meet the inclusion criteria will be eligible to participate in the study. Those included in the intervention phase will have IgE testing and an oral food challenge (OFC) to test and placebo products, in a randomised double-blind design. Children with a negative reaction to both test and placebo products will receive the test product for a period of 7 days (open challenge). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04519827
Study type Interventional
Source Dr. Schär AG / SPA
Contact
Status Completed
Phase N/A
Start date May 21, 2020
Completion date November 29, 2023

See also
  Status Clinical Trial Phase
Completed NCT04604912 - Biomarkers in Food Allergy Diagnosis
Suspended NCT03352856 - Food Challenge With Barley Starch as Active Comparator N/A
Recruiting NCT06069492 - Randomized Controlled Trial for Wheat Oral Immunotherapy N/A
Not yet recruiting NCT05826405 - Efficacy and Safety of Oral Cashew Nut Immunotherapy in Children (CAJESITO)
Not yet recruiting NCT04828317 - Alpha-gal Pork Challenge N/A
Active, not recruiting NCT03667651 - The PEBBLES Study - Testing a Strategy for Preventing Eczema and Food Allergy in High Risk Infants Phase 3
Terminated NCT03504774 - Food Allergen OIT for Shrimp and Cashew Phase 2
Completed NCT04400214 - The Food Allergy Superheroes Training (FAST) Program N/A
Not yet recruiting NCT06167564 - Allergy Diagnostic Test Based on Microchip Technology N/A
Completed NCT04774796 - Group CBT Intervention for Parents of Children With Food Allergy N/A
Completed NCT03861910 - Dietary Choice for the Management of Cow's Milk Allergy Influences Other Allergic Manifestations
Recruiting NCT05407012 - TRANS-FOODS: Preventing Peanut Allergy Through Improved Understanding of the Transcutaneous Sensitisation Route, Novel Food Processing and Skin Care Adaptations N/A
Not yet recruiting NCT04329078 - Relevance of Sensitization to Legumes in Children Allergic to Peanut