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

This study has been terminated.

Sponsors and Collaborators:	Meiji University of Oriental Medicine Kyoto Prefectural University of Medicine
Information provided by:	Meiji University of Oriental Medicine
ClinicalTrials.gov Identifier:	NCT00276445

Purpose

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

Condition	Intervention	Phase
Allergic Conjunctivitis	Drug: beta-1,3-glucan	Phase IV

MedlinePlus related topics: Allergy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan - A Double-Blind Randomized Study

Further study details as provided by Meiji University of Oriental Medicine:

Primary Outcome Measures:

Symptoms were assessed clinically by score on a allergic symptom rating scale.

Secondary Outcome Measures:

Total IgE and allergen specific IgE were measured.
The binding capacity of beta-1,3-glucan to peripheral CD14+ cells were assessed.

Estimated Enrollment:	60
Study Start Date:	January 2004
Estimated Study Completion Date:	June 2004

Detailed 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

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276445

Locations

Japan
Meiji University of Oriental Medicine
Kyoto, Japan, 629-0392

Sponsors and Collaborators

Meiji University of Oriental Medicine

Kyoto Prefectural University of Medicine

Investigators

Principal Investigator:	Jun Yamada, M.D. Ph.D.	Meiji University of Oriental Medicine
Study Director:	Junji Hamuro, Ph.D.	Kyoto Prefectural University of Medicine
Study Chair:	Shigeru Kinoshita, M.D. Ph.D.	Kyoto Prefectural University of Medicine

More Information

Additional Information:

Meiji University of Oriental Medicine This link exits the ClinicalTrials.gov site

Publications:

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(194):687-8. No abstract available.

Study ID Numbers:	15-58-2, Japanese Minis. Edu. 17791261
Study First Received:	January 12, 2006
Last Updated:	November 6, 2006
ClinicalTrials.gov Identifier:	NCT00276445
Health Authority:	Japan: Institutional Review Board

Keywords provided by Meiji University of Oriental Medicine:

allergy
Allergy conjunctivitis
beta-1-3glucan
Th1/Th2

Study placed in the following topic categories:

Hypersensitivity
Conjunctivitis, Allergic
Eye Diseases
Hypersensitivity, Immediate

Conjunctivitis
Beta-1,3-glucan
Conjunctival Diseases

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009