Supplemental effect of fermented soy product on rush oral immunotherapy (F-SOI)- Double blind - randomized placebo control trial

Not Applicable

• Conditions: food allergy

• Registration Number: JPRN-UMIN000022826
• Lead Sponsor: Aichi Children's Health and Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-21
• Study Completion: 2018-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

patients with severe comorbidity patients with uncontrollable asthma or atopic dermatitis patients with severe food allergy for soybeans patients whom the doctor assess ineligible

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The total score of allergic reaction score plus rescue drug score during rash phase of OIT.

Secondary Outcome Measures

Name	Time	Method
The amount of food consumption and the proportion of patients who reached the target dose (20g of boiled egg, 100ml of milk and 100g of udon noodle) at discharge and at 3 months after discharge. The changes in value of laboratory data (e.g. specific IgE titer) The changes in value of the threshold dose of antigen and severity of allergic reaction provoked in OFCs