VLOIT study for peanut

JRCT ID: jRCTs041180049

Registered date:20/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Food allergy
• Date of first enrollment: 20/02/2019
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Very low-dose oral immunotherapy with peanut. Participants take 0.0092 mg of peanut protein daily as first dose. The doses are increased double times every 7 intakes up to 5.74 mg of peanut protein.

Outcome(s)

• Primary Outcome: Difference of successfull comsumed dose of peanut oral food challenge between baseline and month 12.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 15age old
• Gender: Both
• Include 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).
• Exclude 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.

Related Information

• Primary Sponsor: Natsume Osamu
• Secondary ID(s): UMIN000027102