Clinical Trial: Impact of Infant Formula on Resolution of Cow's Milk Allergy

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



Official Title: A Prospective Randomized Controlled Trial to Evaluate the Effect of Infant Formula on the Resolution of Cow's Milk Allergy of Infancy

Brief Summary:

Primary Endpoint

-The percentage of subjects who develop tolerance to cow's milk protein by 12 months post randomization to study formula.

Secondary Endpoints

  • Tolerance

    • The transcriptional profile of milk-specific T cells by clinical outcome.
    • Growth and Weight Velocity
    • Stool Consistency and Frequency
    • The estimated frequency of milk-specific T cells by clinical outcome.
    • The TCR diversity of milk-specific T cells by clinical outcome.
    • The milk allergen component-specific IgE, IgG4 and IgA by clinical outcome.

  • Safety

    • The rate of reported adverse events by treatment group.