NCT00276445

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
Last Updated

November 7, 2006

Status Verified

January 1, 2004

First QC Date

January 12, 2006

Last Update Submit

November 6, 2006

Conditions

Allergic Conjunctivitis

Keywords

allergyAllergy conjunctivitisbeta-1-3glucanTh1/Th2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • Total IgE and allergen specific IgE were measured.

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

Interventions

beta-1,3-glucanDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who had undergone immunotherapy in the previous 5 years
  • a history of other immunological or medically relevant diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meiji University of Oriental Medicine

Kyoto, Kyoto, 629-0392, Japan

Location

Related Publications (1)

  • 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.

    PMID: 5768289BACKGROUND

Related Links

MeSH Terms

Conditions

Conjunctivitis, AllergicHypersensitivity

Interventions

beta-1,3-glucan

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateImmune System Diseases

Study Officials

  • Jun Yamada, M.D. Ph.D.

    Meiji University of Oriental Medicine

    PRINCIPAL INVESTIGATOR

  • Junji Hamuro, Ph.D.

    Kyoto Prefectural University of Medicine

    STUDY DIRECTOR

  • Shigeru Kinoshita, M.D. Ph.D.

    Kyoto Prefectural University of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

January 1, 2004

Study Completion

June 1, 2004

Last Updated

November 7, 2006

Record last verified: 2004-01

Locations

JP(1)