Birch subcutaneous immunotherapy for children with soybean pollen-food allergy syndrome

Efficacy of birch subcutaneous immunotherapy for children with soymilk pollen-food allergy syndrome: A multicenter, open-label, randomized controlled trial - BIRCH trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031260091

Enrollment

Registered

2026-04-27

Start date

2026-06-01

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

Soy milk Pollen-Food Allergy Syndrome Oral allergy syndrome

Interventions

Conduct subcutaneous immunotherapy (SCIT) using birch pollen extract for one year.

E02.095.465.425.450.310, E05.478.610.310

Subcutaneous immunotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients aged 3 years or older but under 18 years at screening (2) Patients diagnosed with soy milk PFAS by an allergist (3) Patients with a positive double-blind, placebo-controlled food challenge (DBPCFC) to 50 ml of soy milk (4) Patients with blood test results showing Gly m 4-specific IgE antibody titers and either alder or birch-specific IgE antibody titers of 0.35 kUA/L or higher (5) Patients for whom written consent has been obtained from a legal guardian or proxy decision-maker and the research subject

Exclusion criteria

Exclusion criteria: (1) Patients with poorly controlled bronchial asthma (C-ACT or ACT score of 19 or below) (2) Patients with poorly controlled atopic dermatitis (EASI score of 16 or above) (3) Patients with concomitant diseases affecting the immune system (e.g., autoimmune diseases, immune complex diseases, immunodeficiency disorders) (4) Patients taking systemic steroids or immunosuppressants on a regular basis at the time of screening (5) Patients who have used a biologic agent within 3 months prior to screening (6) Patients who are pregnant or highly likely to be pregnant (7) Patients deemed inappropriate by the judgment of the principal investigator or co-investigator

Design outcomes

Primary

Measure	Time frame
Tolerance acquisition to 50 ml of soy milk after 12 months	—

Secondary

Measure	Time frame
NRS scores for soy products, apple, peach, and cherry at 12 months Frequency and severity of adverse reactions associated with SCIT administration Change rate of soybean, Gly m 4, alder, birch, apple, peach, and Bet v 1 specific IgE levels after 12 months Change rate of soybean, Gly m 4, birch, Bet v 1 specific IgG and IgG4 levels after 12 months	—

Contacts

Public ContactKen-ichi Nagakura

NHO Sagamihara National Hospital

k.nagakura@foodallergy.jp+81-42-742-8311

Outcome results

None listed

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