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

Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan - A Double-Blind Randomized Study

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00276445
Enrollment
60
Registered
2006-01-13
Start date
2004-01-31
Completion date
2004-06-30
Last updated
2006-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Conjunctivitis

Keywords

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

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

Interventions

DRUGbeta-1,3-glucan

Sponsors

Kyoto Prefectural University of Medicine
CollaboratorOTHER
Meiji University of Oriental Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Symptoms were assessed clinically by score on a allergic symptom rating scale.

Secondary

MeasureTime frame
Total IgE and allergen specific IgE were measured.
The binding capacity of beta-1,3-glucan to peripheral CD14+ cells were assessed.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026