Slow Low-dose Oral Immunotherapy [SLOIT] for children with food allergies - non-randomized control trial
Not Applicable
- Conditions
- food allergy
- Registration Number
- JPRN-UMIN000017416
- Lead Sponsor
- Aichi Children's Health and Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
patients during oral immunotherapy for other food antigen patients with severe comorbidity patients with uncontrollable asthma or atopic dermatitis patients whose parents can not manage adrenalin autoinjector patients who have developed anaphylaxis by tiny antigen (less than 1mL of milk or 1g of boiled egg, udon noodle) within one year before the oral food challenge. patients whom the doctor asses ineligible
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the proportion of patients with negative results of oral food challenge for boiled egg white, cow's milk, udon noodle (0.2 - 0.5 - 1 - 2 - 5g or mL 30min interval)
- Secondary Outcome Measures
Name Time Method Safety and continuity of the therapy. The threshold dose of antigen and severity of allergic reaction provoked in OFCs. The shift of laboratory data (e.g. specific IgE titer) The frequency of rescue drug use and emergency department visit due to expected and unexpected allergic reaction in both groups.