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A before-after study of tolerance induction by very low-dose oral immunotherapy for peanut allergy

A before-after study of tolerance induction by very low-dose oral immunotherapy for peanut allergy - efficacy of peanut VLOIT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027102
Enrollment
20
Registered
2017-05-02
Start date
2017-05-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

food allergy

Interventions

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.

Sponsors

Hamamatsu University School of Medicine, department of pediatrics
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who have result of peanut SPT and blood test (total IgE, peanut s-IgE and Ara h 2 s-IgE) within 3 months and 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

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.

Design outcomes

Primary

MeasureTime frame
Difference of successfull comsumed dose of peanut oral food challenge between baseline and month 12.

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactNatsume Osamu

Hamamatsu University School of Medicine department of pediatrics

natsumeo@hama-med.ac.jp053-435-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026