Clinical Trial: A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy

Brief Summary: The purpose of this study is to determine if small oral doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.

Detailed Summary: This is a prospective, multi-center, clinical trial involving children aged 6 to 21 years with persistent cow's milk allergy. These children will be recruited from 2 sites (Johns Hopkins and Duke University) and will undergo initial screening and double-blind, placebo-controlled, food challenge (DBPCFC) to confirm threshold dose for reactivity to milk. Patients will be treated with milk oral immunotherapy (OIT) or placebo for 22-30 weeks. Those who reach an adequate maintenance dose for OIT will undergo a second DBPCFC. Those who develop desensitization will continue with daily milk intake and undergo a third DBPCFC. Those in the treatment group who are not desensitized will return to strict avoidance. Those in placebo group will be offered to begin treatment or continue with strict milk avoidance. Symptom and diet information will be collected initially and at regular intervals. Bloodwork, skin prick tests (SPTs), pulmonary function tests (PFTs), and oral secretion samples will be done initially and at periodic intervals.
Sponsor: Johns Hopkins University

Current Primary Outcome: The Median Milk Threshold Dose Inducing a Reaction [ Time Frame: Baseline and 23 weeks ]

Original Primary Outcome: The percentage of patients who can tolerate four times the initial OFC threshold dose or the maximum OFC dose of 8 grams after therapy.

Current Secondary Outcome:

  • Changes in Cow Milk-IgE [ Time Frame: Baseline and 23 weeks ]
    IgE is measured in kilounits per liter (kU/L). Measurements were obtained at Baseline and at 23 weeks
  • Changes in Cow Milk Immunoglobulin G4 (IgG4) [ Time Frame: Baseline and 23 weeks ]
    IgG4 is measured in ug/mL. Measurements were obtained at Baseline and at 23 weeks


Original Secondary Outcome:

  • Incidence of protocol-defined severe hypersensitivity reactions during the study
  • Incidence of all serious adverse events during the study
  • Incidence of all adverse events
  • To assess for any changes in milk-IgE, milk-IgG4, and skin test reactivity during OIT and as milk allergy persists or resolves.


Information By: Johns Hopkins University

Dates:
Date Received: April 23, 2007
Date Started: August 2006
Date Completion:
Last Updated: April 18, 2017
Last Verified: April 2017