NCT04519827

A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula

A Prospective, Randomised, Double-blind Controlled Study, to Evaluate the Safety/Hypoallergenicity of a New Rice-based Hydrolysate Formula With New Ingredient for Infants and Children With Diagnosed Cow's Milk Allergy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Dr. Schär AG / SPA · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Allergy;Food

Interventions

Type	Name	Description
OTHER	New Rice-based hydrolysate	A rice-based hydrolysed infant formula with new ingredient
OTHER	Amino Acid-based infant formula	An amino acid-based infant formula

Timeline

• Start date: 2020-05-21
• Primary completion: 2023-11-29
• Completion: 2023-11-29
• First posted: 2020-08-20
• Last updated: 2023-12-08

Locations

4 sites across 2 countries: Italy, Spain