CompletedNot Applicable

Evaluation of the Efficacy of a New Formula in Infants With Cow's Milk Protein Allergy

Belgium

Plain-language summary

The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.

Who can participate

Age range2 Weeks – 6 Months

SexALL

See this in plain English?

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

Inclusion Criteria: * Infants between 2 weeks and 6 months old * In whom cow's Milk Protein Allergy has been proved by a food challenge performed during the previous month Exclusion Criteria: * Exclusively breast fed infants * Preterm infants * Infants already fed with an extensively hydrolyzed formula with no improvement of the symptoms. * Infants fed an amino acid based formula * Infants who had an anaphylactic reaction in the past

What they're measuring

Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score

Timeframe: at 4 weeks

Trial details

NCT IDNCT01998074

SponsorUnited Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Milk Hypersensitivity trials