VLOIT study for peanut

Phase 2

• Conditions: Food allergy

• Registration Number: JPRN-jRCTs041180049
• Lead Sponsor: atsume Osamu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-20
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients who eliminate peanut. Patients with positive open label oral food challenge (exclude oral around symptom) less than or equal to 1.4 g of peanuts, which contained 35.7 mg peanut protein (only VLOIT group).

Exclusion Criteria

Patients with uncontrollable asthma or atopic dermatitis. Patients with chronic urticaria. Patients who do immunotherapy of other foods within 2 hours before and after this treatment. Patients whom the doctor assesses ineligible.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference of successfull comsumed dose of peanut oral food challenge between baseline and month 12.

Secondary Outcome Measures

Name	Time	Method
Difference of peanut specific-IgE and IgG4, Ara h 2 specific-IgE and IgG4, and wheal size of peanut SPTs between baseline and month 12. Difference of peanut specific-IgE at month 12 between the VLOIT group and the Control group, which consisted of peanut specific-IgE at baseline matched 20 patients who avoid peanut for 12 months. Difference of absolute change in wheal size of peanut SPTs from baseline to month 12 between the VLOIT group and the Control group. Difference of parcentage change in peanut specific-IgG4 and Ara h 2 specific-IgE and IgG4 from baseline to month 12 between the VLOIT group and the Control group.