Skip to content

Novel treatment for pollen-food allergy syndrome using hypoallergenic pollen

Novel allergen immunotherapy for pollen-food allergy syndrome using birch pollen-galactomannan conjugate

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031230008
Enrollment
5
Registered
2023-04-06
Start date
2023-05-20
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

pollen-food allergy syndrome

Interventions

Administer birch pollen-galactomannan conjugate

Sponsors

Komatsuzaki Keiko
Lead Sponsor
Miyazaki Yasunari
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who are positive for alder or white birch-specific IgE and exhibit oral allergy symptoms due to raw apples 2) Age between 18 and 64 at the time of obtaining consent 3) Subjects who have obtained written informed consent of their own free will after sufficient understanding to participate in this research. 4) Those who can go to Tokyo Medical and Dental University Hospital / Ikebukuro Otani Clinic

Exclusion criteria

Exclusion criteria: 1)Patients with a history of anaphylaxis to raw apples 2)Patients who have undergone allergen immunotherapy with Betulaceae pollen in the past 3) Subjects who performed a skin prick test with birch pollen-galactomannan conjugate ointment before the start and compared with the positive control, the wheal diameter was 1/2 or more or 3 mm or more larger than the wheal diameter of the negative control. 4) Patients who have undergone or are undergoing treatment with biological agents such as anti-IgE antibody, anti-IL-5 antibody, anti-IL-4a antibody, anti-TSLP antibody 5)Patients with suspected infectious disease within 4 weeks before enrollment 6) Patients with allergic rhinitis-like diseases such as acute rhinitis, suspected acute/chronic sinusitis, and eosinophilic sinusitis 7)Patients who received treatment with non-topical steroids or immunosuppressants within 4 weeks before enrollment 8) Patients with uncontrolled bronchial asthma, patients undergoing treatment or follow-up for malignant disease 9) Women who are pregnant or may become pregnant 10) Lactating women 11) Patients participating in other clinical trials or clinical studies at the time of enrollment 12) In addition, patients who are judged inappropriate by the principal investigator or researcher to conduct this research safely

Design outcomes

Primary

MeasureTime frame
Raw apple oral challenge intake threshold and VASmm Wheal diameter of skin prick test with raw apple and birch extract

Secondary

MeasureTime frame
Secondary efficacy endpoints Serum birch-specific IgE, IgG, IgG1, IgG4, serum Bet v 1-specific IgE, IgG, IgG4 Saliva birch-specific IgA, IgG, serum and saliva TGF-b and IL-10 Total IgE, peripheral blood eosinophil count Nasal eosinophil count

Contacts

Public ContactKeiko Komatsuzaki

Institute of Science Tokyo

komatsuzaki.hsc@tmd.ac.jp+81-3-5803-5081

Outcome results

None listed

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