Allergy;Food Clinical Trial
— CHARMOfficial title:
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
Verified date | December 2023 |
Source | Dr. Schär AG / SPA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | November 29, 2023 |
Est. primary completion date | November 29, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 10 Years |
Eligibility | Inclusion Criteria: 1. Children <10 yrs of age 2. Proven IgE-mediated CMA 3. >2500g at birth 4. > 37 weeks gestation 5. Written informed consent provided by parent(s)/guardian Exclusion Criteria: 1. Infants/children with severe concurrent illness (other than food allergy/CMA) 2. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements. 3. Participation in other studies involving use of milk replacement products designed to treat/manage CMA within two weeks prior to entry into this study 4. Current participation in OIT to Cow's Milk 5. Diagnosis of anaphylaxis to Cow's Milk 6. Diagnosis of rice allergy |
Country | Name | City | State |
---|---|---|---|
Italy | Meyer Children's Hospital | Florence | |
Italy | Spett.le Universita degli Studi di Napoli ''Federico II'' | Napoli | |
Italy | Hospital Infantile Regina Margherita. | Turin | |
Spain | Hospital Sant Joan de Déu Barcelona 2020, | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Dr. Schär AG / SPA |
Italy, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hypoallergenicity | 90% of children tolerate the TEST formula with a 95% CI - using the double blind placebo controlled food challenge and open challenge (Test vs. placebo). | 7 days open challenge |
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