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
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Woburn Pediatric Associates — Woburn, Massachusetts, United States
Full record on ClinicalTrials.gov
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