Clinical Trial: Safety of Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 4 Study: Milk Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
Brief Summary: The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Detailed Summary:
Eligibility criteria:
Age 6 - 16 yrs
- IgE-mediated milk allergy
- and milk provocation within 3 months prior to or an documented accidental milk contact with clear immediate symptoms
Outcome measures:
- number of patients with successful desensitization (195 - 200 ml milk per day)
- number of patients with adverse events
Sponsor: Tampere University Hospital
Current Primary Outcome: Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Number of participants drinking 2 dl/day of milk (success in desensitization) [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Tampere University Hospital
Dates:
Date Received: February 24, 2011
Date Started: February 2008
Date Completion:
Last Updated: January 2, 2017
Last Verified: January 2017
