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

This study has been terminated.
Sponsor:
Collaborator:
Kyoto Prefectural University of Medicine
Information provided by:
Meiji University of Oriental Medicine
ClinicalTrials.gov Identifier:
NCT00276445
First received: January 12, 2006
Last updated: November 6, 2006
Last verified: January 2004
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan - A Double-Blind Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Allergy Pinkeye
U.S. FDA Resources

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:

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

Keywords provided by Meiji University of Oriental Medicine:
allergy
Allergy conjunctivitis
beta-1-3glucan
Th1/Th2

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Beta-1,3-glucan
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013