A prospective study of tolerance induction by continued very low-dose oral immunotherapy (VLOIT) for peanut allergy

A prospective study of tolerance induction by continued very low-dose oral immunotherapy (VLOIT) for peanut allergy - VLOIT on study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034808

Enrollment

Registered

2018-11-07

Start date

2018-11-07

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

Participants take 5.7-143 mg of peanut protein daily for two years. Participants continue removing peanut.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Participants of VLOIT study (UMIN000027102) 2.Patients under 16 years old. 3.Patients who agreed to participate in this study in writing.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The difference of negative rate of OFC with 14 g of peanuts between the VLOIT group and the removal group after 36 months.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactNatsume Osamu

Hamamatsu University School of Medicine department of pediatrics

natsumeo@hama-med.ac.jp0534352111

Outcome results

None listed

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