JPRN-jRCTs031230008Active, not recruitingPhase 1
ovel allergen immunotherapy for pollen-food allergy syndrome using birch pollen-galactomannan conjugate
Komatsuzaki Keiko0 sites5 target enrollmentStarted: April 6, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 5
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to <= 64age old (—)
- Sex
- All
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
- •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
Investigators
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