Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan

Allergic Conjunctivitis Clinical Trial

Official title:

Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan - A Double-Blind Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00276445
• Other study ID #: 15-58-2
• Secondary ID: Japanese Minis.
• Status: Terminated
• Phase: Phase 4
• First received: January 12, 2006
• Last updated: November 6, 2006
• Start date: January 2004
• Est. completion date: June 2004

Study information

• Verified date: January 2004
• Source: Meiji University of Oriental Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Intravenous- injection of beta-1,3-glucan in human is known to induce T helper type 1 response, while oral uptake did not. It was examined whether superfine dispersed beta-1,3-glucan (SDG) contrived to absorbed by intestinal mucosa would alleviate allergic symptoms by per-oral ingestion

Description:

Beta-1,3-glucan made from Japanese mushroom is commercially available for healthy foodstuffs. Allergy patients were orally administrated either SDG (n=30) or non-dispersed beta-1,3-glucan (NDG, n=30) and allergic symptoms were assessed clinically, by the double-blind, placebo-controlled, randomized study

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: June 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• history of seasonal allergic conjunctivitis with or without rhinitis in spring (Japanese cedar pollen season) every year

• positive allergen specific IgE (> 30 IU/ml) or positive skin prick test result (wheal diameter > 3mm) to Japanese cedar, Orchard Grass pollen, or house dust-mite extract

Exclusion Criteria:

• Patients who had undergone immunotherapy in the previous 5 years

• a history of other immunological or medically relevant diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• beta-1,3-glucan

Locations

Country	Name	City	State
Japan	Meiji University of Oriental Medicine	Kyoto

Sponsors (2)

Lead Sponsor	Collaborator
Meiji University of Oriental Medicine	Kyoto Prefectural University of Medicine

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Chihara G, Maeda Y, Hamuro J, Sasaki T, Fukuoka F. Inhibition of mouse sarcoma 180 by polysaccharides from Lentinus edodes (Berk.) sing. Nature. 1969 May 17;222(5194):687-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms were assessed clinically by score on a allergic symptom rating scale.
Secondary	Total IgE and allergen specific IgE were measured.
Secondary	The binding capacity of beta-1,3-glucan to peripheral CD14+ cells were assessed.

External Links

•   Meiji University of Oriental Medicine