Effect of hypoallergenic birch pollen on healthy people

JRCT ID: jRCTs031210524

Registered date:27/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy volunteer
• Date of first enrollment: 27/12/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Administer polysaccharide-modified birch pollen or placebo once daily.

Outcome(s)

• Primary Outcome: Serum Birch-specific IgE, IgG, IgG4, Serum Bet v 1-specific IgE, IgG, IgG4 Salum Birch-specific IgA and IgG measured value

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 64age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Komatsuzaki Keiko
• Secondary Sponsor: WAKO FILTER TECHNOLOGY Co.,Ltd.