Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan
This study has been terminated.
Sponsor:
Meiji University of Oriental Medicine
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
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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 |
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 (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00276445
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 |
ClinicalTrials.gov processed this record on September 28, 2016