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Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins

Cow Milk Allergy Clinical Trial

Official title:
Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins (TRHF 2017) in Children With Confirmed Immunoglobulin E (IgE) or Non-immunoglobulin E-mediated Cow's Milk Allergy (CMA)

Clinical Trial Summary

The aim of this study is to show the hypoallergenicity of a new thickened rice based formula (TRHF) through a double blind placebo controlled food challenge (DBPCFC), as recommended by the American Academy of Pediatrics, in subjects with IgE-mediated CMA and in subjects with non-IgE-mediated CMA.

Clinical Trial Description

The study is made of 2 different steps : 1st step is a double blind randomised food challenge where the new formula is compared to a placebo. The second part of the trial consists in an open phase during which all infants will be fed with the study formula. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03557671
Study type Interventional
Source United Pharmaceuticals
Contact
Status Completed
Phase N/A
Start date August 23, 2018
Completion date September 21, 2020
View Details
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