Impact of Infant Formula on Resolution of Cow's Milk Allergy

Stopped early · Phase 2

Conditions studied: Milk Allergy

In brief

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.

Key facts

Study ID
NCT02719405
Run by
Massachusetts General Hospital
People needed
49
Starts
2016-02-01
Expected to finish
2018-02-01
Last updated by the study team
2018-07-13

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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