Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04519827 |
Other study ID # |
CHARM-01-2020 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 21, 2020 |
Est. completion date |
November 29, 2023 |
Study information
Verified date |
December 2023 |
Source |
Dr. Schär AG / SPA |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
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.
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).