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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 19, 2014