Clinical Trial: Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multicenter, Randomized, Controlled, Cross-over Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy

Brief Summary: This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of the new amino acid-based formula in infants and children aged< 12 years with documented cow's milk protein allergy (CMPA).

Detailed Summary: Not Provided
Sponsor: Laboratorios Ordesa

Current Primary Outcome: Hypoallergenicity as assessed by reaction to Amino-acid Based Infant Formula [ Time Frame: 14 days ]

To demonstrate that the test formula does not cause immediate and/or delayed allergic reactions to a double blind placebo control food challenge (DBPCFC) and/or a subsequent open food challenge (OFC).


Original Primary Outcome: Same as current

Current Secondary Outcome: Tolerability to the test formula [ Time Frame: 14 days ]

Record of adverse events during the study period


Original Secondary Outcome: Same as current

Information By: Laboratorios Ordesa

Dates:
Date Received: February 11, 2015
Date Started: April 2015
Date Completion: November 2016
Last Updated: July 19, 2016
Last Verified: July 2016