A pilot study to explore the efficacy and safety of jam oral immunotherapy with hypoallergenized cow's milk for children with cow's milk allergy
Phase 2
- Conditions
- food allergy (cow's milk)
- Registration Number
- JPRN-UMIN000018372
- Lead Sponsor
- ational Center for Child Health and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients with non-immediate reaction to cow's milk 2. Patients with uncontrolled asthma, atopic dermatitis or urticaria 3. Patients with pineapple or soy allergy 4. Patients who have treatment history or plan with omalizumab 5. Patients who were undergoing oral immunotherapy of build-up phase for other food antigen
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The threshold change of double blind placebo controlled oral food challenge test
- Secondary Outcome Measures
Name Time Method 1. Effectiveness Change of specific IgE and IgG4 level for cow's milk, casein, B-lactoglobulin 2. Safety a. The proportion of the patients who experienced allergic reactions within 2 hours after the ingestion of the hypoallergenized milk b. The frequency of allergic reactions within 2 hours after the ingestion of the hypoallergenized milk 3. Edibility of jam containing hypoallergenized cow's milk 4. QOL assessment by the parents and of the parents