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

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)

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.

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.

Inclusion Criteria:

• with suspected CMA or with a CMA diagnosed by a DBPCFC performed in the last 2 months prior to inclusion
• free of clinical allergic symptoms for at least one week (i.e. successfully fed an elimination diet);
• whose parents signed the informed consent

Exclusion Criteria:

• mainly breast fed, drinking less than 250ml of formula/day, presenting any situation, which, according to the investigator, may interfere with the study participation or lead to a particular risk for the subject