Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic.
Not Applicable
- Conditions
- food allergy
- Registration Number
- JPRN-UMIN000013769
- Lead Sponsor
- ational Hospital Organization Sagamihara National Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
The threshold for eliciting positive symptoms is less than or equal to a thirty-second hen's egg, 3ml of cow's milk, or 3g of Udon noodles by oral food challenge test. The subject who is treated by adrenaline injection at oral food challenge test just before this study. The subject who has not-well treated atopic dermatitis, bronchial asthma, or any underlying disease. The subject who is not appropriate for oral immunotherapy, judged by medical doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The purpose of this study is to clarify dose dependent outcome, regarding tolerance acquisition and incidence rate of symptoms by outpatient oral immunotherapy. Patients are enrolled in two groups, which are divided by target amounts of OIT ingestion as 100% or 25% of maximum ingestion amount.
- Secondary Outcome Measures
Name Time Method To investigate the efficacy of oral immunotherapy, compared to natural course without the therapy. To confirm the safety of outpatient oral immunotherapy for mild and moderate food allergic children. To analyze the reactivity for oral immunotherapy, stratified by their severity of food allergy. Regarding the OIT patients who haven't reached tolerance at 1 year follow up, they can continue OIT for longer period with their informed consent with its will for participation in advance. The outcome at 2 years' follow up is analyzed in addition to that at 1 year.