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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
Est. primary completion date
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


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.
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