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

Phase 4TerminatedNCT00276445

Meiji University of Oriental Medicine60 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Allergic Conjunctivitis

Interventions

beta-1,3-glucanDRUG

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Meiji University of Oriental Medicine

Kyoto, Kyoto, Japan

Outcomes

Primary Outcomes

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

Secondary Outcomes

Total IgE and allergen specific IgE were measured.

The binding capacity of beta-1,3-glucan to peripheral CD14+ cells were assessed.

Data from ClinicalTrials.gov

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