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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:
ClinicalTrials.gov Identifier:
NCT00276445
First Posted: January 13, 2006
Last Update Posted: November 7, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kyoto Prefectural University of Medicine
Information provided by:
Meiji University of Oriental Medicine
  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
Intervention Model: Crossover Assignment
Masking: Double
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:


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

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
ClinicalTrials.gov Identifier: NCT00276445     History of Changes
Other Study ID Numbers: 15-58-2
Japanese Minis. Edu. 17791261
First Submitted: January 12, 2006
First Posted: January 13, 2006
Last Update Posted: November 7, 2006
Last Verified: January 2004

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