A randomized controlled trial of low-dose oral immunotherapy for preschool-aged children with food allergy
Not Applicable
Recruiting
- Conditions
- food allergy
- Registration Number
- JPRN-UMIN000041637
- Lead Sponsor
- ational Hospital Organization Sagamihara National Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 216
Inclusion Criteria
Not provided
Exclusion Criteria
The subject who has poorly treated atopic dermatitis and bronchial asthma. The subject suspected with Food-protein induced enterocolitis syndrome. The subject whose body weight is less than 10 kg. The subject who seems inappropriate candidate for oral immunotherapy as judged by a medical doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of negative oral food challenge to the low-dose* after 1 year *The low-dose is defined as"1/25 of a heated whole hen's egg (250mg of hen's egg protein), 3ml of cow's milk, 2g of udon, 0.5g of peanut, walnut, cashew, hazelnut, almond, and macadamia nut". Walnut, cashew, hazelnut, almond, and macadamia nut were added on November 6, 2020, before enrollment of first patient.
- Secondary Outcome Measures
Name Time Method