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

NCT ID: NCT00276445

Last Updated: 2006-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-06-30

Brief Summary

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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

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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

Conditions

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Allergic Conjunctivitis

Keywords

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allergy Allergy conjunctivitis beta-1-3glucan Th1/Th2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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beta-1,3-glucan

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kyoto Prefectural University of Medicine

OTHER

Sponsor Role collaborator

Meiji University of Oriental Medicine

OTHER

Sponsor Role lead

Principal Investigators

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Jun Yamada, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Meiji University of Oriental Medicine

Junji Hamuro, Ph.D.

Role: STUDY_DIRECTOR

Kyoto Prefectural University of Medicine

Shigeru Kinoshita, M.D. Ph.D.

Role: STUDY_CHAIR

Kyoto Prefectural University of Medicine

Locations

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Meiji University of Oriental Medicine

Kyoto, Kyoto, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND
PMID: 5768289 (View on PubMed)

Related Links

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http://www.meiji-u.ac.jp/

Meiji University of Oriental Medicine

Other Identifiers

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Japanese Minis. Edu. 17791261

Identifier Type: -

Identifier Source: secondary_id

15-58-2

Identifier Type: -

Identifier Source: org_study_id