IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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) |
| 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
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
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 |
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 August 17, 2017