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

United Pharmaceuticals

Status: Completed

Conditions: Cow Milk Allergy

Treatments: Dietary Supplement: placebo; Dietary Supplement: rice formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT03557671

UP2017-Promyce

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 1 to 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

TRHF - Placebo

Experimental group

Description:

Each subjects will receive both TRHF and placebo formula during the 1st part of the study

Treatment:

Dietary Supplement: rice formula

Dietary Supplement: placebo

Placebo - TRHF

Placebo Comparator group

Description:

Each subjects will receive both TRHF and placebo formula during the 1st part of the study

Treatment:

Dietary Supplement: rice formula

Dietary Supplement: placebo