A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Allergy;Food

Intervention / Treatment
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* Other: New Rice-based hydrolysate
* Other: Amino Acid-based infant formula


Participation Criteria
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Eligibility Criteria
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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 Current participation in OIT to Cow's Milk Diagnosis of anaphylaxis to Cow's Milk Diagnosis of rice allergy

Ages Eligible for Study
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Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Rice-based hydrolysate<br>The TEST formula is a new Rice-based hydrolysate with new ingredient. | Other: New Rice-based hydrolysate<br>* A rice-based hydrolysed infant formula with new ingredient<br>|
| Placebo Comparator: Amino-acid based formula<br>The PLACEBO is an Amino-acid based formula. | Other: Amino Acid-based infant formula<br>* An amino acid-based infant formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cow's Milk Protein Allergy (CMPA), Cow's Milk Allergy (CMA), CHILDREN