CompletedNot Applicable

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

Belgium, France, Italy72 participantsStarted 2018-08-23

Plain-language 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.

Who can participate

Age range1 Month – 36 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

hypoallergenicity

Timeframe: 7 days

Trial details

NCT IDNCT03557671

SponsorUnited Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-09-21

View on ClinicalTrials.gov More Cow Milk Allergy trials