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

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ClinicalTrials.gov Identifier: NCT00276445
Recruitment Status : Terminated
First Posted : January 13, 2006
Last Update Posted : November 7, 2006
Sponsor:
Collaborator:
Kyoto Prefectural University of Medicine
Information provided by:
Meiji University of Oriental Medicine

Tracking Information
First Submitted Date  ICMJE January 12, 2006
First Posted Date  ICMJE January 13, 2006
Last Update Posted Date November 7, 2006
Study Start Date  ICMJE January 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2006)
Symptoms were assessed clinically by score on a allergic symptom rating scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00276445 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2006)
  • Total IgE and allergen specific IgE were measured.
  • The binding capacity of beta-1,3-glucan to peripheral CD14+ cells were assessed.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2006)
  • Total IgE and allergen specific IgE were measurred.
  • The binding capacity of beta-1,3-glucan to peripheral CD14+ cells were assessed.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan
Official Title  ICMJE Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan - A Double-Blind Randomized Study
Brief 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Allergic Conjunctivitis
Intervention  ICMJE Drug: beta-1,3-glucan
Study Arms  ICMJE Not Provided
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(5194):687-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: January 12, 2006)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00276445
Other Study ID Numbers  ICMJE 15-58-2
Japanese Minis. Edu. 17791261
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Meiji University of Oriental Medicine
Collaborators  ICMJE Kyoto Prefectural University of Medicine
Investigators  ICMJE
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
PRS Account Meiji University of Oriental Medicine
Verification Date January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP