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Effect of hypoallergenic birch pollen on healthy people

Immune response of polysaccharide-modified birch pollen to healthy individuals

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031210524
Enrollment
10
Registered
2021-12-27
Start date
2021-12-27
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

Healthy volunteer pollen-food allergy syndrome, oral allergy syndrome

Interventions

Administer polysaccharide-modified birch pollen or placebo once daily.

Sponsors

Komatsuzaki Keiko
Lead Sponsor
WAKO FILTER TECHNOLOGY Co.,Ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Target humans who meet all of the following criteria. 1) Healthy people with alder and birch-specific IgE negative 2) Age is 18 to 64 years old at the time of consent acquisition 3) Those who have obtained the voluntary consent of the document after fully understanding the participation in this research. 4) Persons who can go to the University Health Care Center

Exclusion criteria

Exclusion criteria: Those who meet any of the following conditions are not eligible. 1) Patients with perennial or intranasal disease currently under treatment or follow-up Persons with findings pointed out in the medical examination and instructed to follow up every 12 months can participate 2) Patients who have previously received allergen immunotherapy with birch pollen 3) Before the start, a skin prick test was performed with a birch pollen-galactomannan complex ointment, and the wheal diameter was 1/2 or more or 3 mm or more larger than the wheal diameter of the negative control compared to the positive control. 4) Patients treated with anti-IgE antibody preparation 5) Patients suspected of having an infectious disease within 4 weeks before registration 6) Patients with suspected acute rhinitis and acute / chronic sinusitis, which are similar to allergic rhinitis 7) Patients treated with non-external steroids within 4 weeks prior to enrollment 8) Those who have a history of allergies to saccharin 9) Pregnant or potentially pregnant women 10) Lactating female 11) Patients participating in other clinical trials or clinical studies at the time of enrollment 12) In addition, the principal investigator or researcher may safely carry out this research. Patients judged to be inappropriate

Design outcomes

Primary

MeasureTime frame
Serum Birch-specific IgE, IgG, IgG4, Serum Bet v 1-specific IgE, IgG, IgG4 Salum Birch-specific IgA and IgG measured value

Secondary

MeasureTime frame
Skin prick test Serum cytokine concentration Saliva cytokine concentration Anterior nasal findings Total IgE, peripheral blood eosinophil count Eosinophil count(nasal discharge) Nasal mucosa provocation test

Contacts

Public ContactKeiko Komatsuzaki

Tokyo Medical and Dental University

komatsuzaki.hsc@tmd.ac.jp+81-358035081

Outcome results

None listed

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