Back to resultsAlleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan
Primary Purpose
Allergic Conjunctivitis
Status
Terminated
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
beta-1,3-glucan
Sponsored by
About this trial
This is an interventional prevention trial for Allergic Conjunctivitis focused on measuring allergy, Allergy conjunctivitis, beta-1-3glucan, Th1/Th2
Eligibility 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
Sites / Locations
- Meiji University of Oriental Medicine
Outcomes
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.
Full Information
NCT ID
NCT00276445
First Posted
January 12, 2006
Last Updated
November 6, 2006
Sponsor
Meiji University of Oriental Medicine
Collaborators
Kyoto Prefectural University of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00276445
Brief Title
Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan
Official Title
Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan - A Double-Blind Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2004
Overall Recruitment Status
Terminated
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Meiji University of Oriental Medicine
Collaborators
Kyoto Prefectural University of Medicine
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
allergy, Allergy conjunctivitis, beta-1-3glucan, Th1/Th2
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
beta-1,3-glucan
Primary Outcome Measure Information:
Title
Symptoms were assessed clinically by score on a allergic symptom rating scale.
Secondary Outcome Measure Information:
Title
Total IgE and allergen specific IgE were measured.
Title
The binding capacity of beta-1,3-glucan to peripheral CD14+ cells were assessed.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Yamada, M.D. Ph.D.
Organizational Affiliation
Meiji University of Oriental Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Junji Hamuro, Ph.D.
Organizational Affiliation
Kyoto Prefectural University of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shigeru Kinoshita, M.D. Ph.D.
Organizational Affiliation
Kyoto Prefectural University of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Meiji University of Oriental Medicine
City
Kyoto
ZIP/Postal Code
629-0392
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
5768289
Citation
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. doi: 10.1038/222687a0. No abstract available.
Results Reference
background
Links:
URL
http://www.meiji-u.ac.jp/
Description
Meiji University of Oriental Medicine
Learn more about this trial
Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan
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