A prospective study of tolerance induction by continued very low-dose oral immunotherapy (VLOIT) for peanut allergy
Phase 1
- Conditions
- Food Allergy
- Registration Number
- JPRN-UMIN000034808
- Lead Sponsor
- Hamamatsu University School of Medicine, department of pediatrics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patients whom atopic dermatitis or bronchial asthma are uncontrolled. 2.Patients with chronic urticaria. 3.Patients whom undergo another oral immunotherapy within 2 hours. 4.Patients who the doctor assesses ineligible. 5.Patient who were administered anti-histamine or LTRA for peanut allergy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference of negative rate of OFC with 14 g of peanuts between the VLOIT group and the removal group after 36 months.
- Secondary Outcome Measures
Name Time Method The difference of absolute change in successful consumed dose from baseline to months 24 and 36 between the VLOIT group and the removal group. The difference of peanut specific-IgE and IgG4, Ara h2 specific-IgE and IgG4, and wheal size of peanut SPTs between baseline and month 24 or 36. The difference of absolute change in wheal size of peanut SPTs from baseline to months 24 and 36 between the VLOIT group and the removal group. The difference of percentage change in peanut-specific IgE and IgG4, Ara h 2-specific IgE and IgG4 from baseline to months 24 and 36 between the VLOIT group and the removal group.