Allergic ConjunctivitisPhase 4NCT00276445
Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan
A Phase 4 study testing beta-1,3-glucan in people with Allergic Conjunctivitis, run by Meiji University of Oriental Medicine at 1 site in Japan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- beta-1,3-glucan
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2004to Jun 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who had undergone immunotherapy in the previous 5 years
- a history of other immunological or medically relevant diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan - A Double-Blind Randomized Study
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
Read the 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
- Conditions
- Allergic Conjunctivitis
- Being tested
- beta-1,3-glucan
- Keywords
- allergy, Allergy conjunctivitis, beta-1-3glucan, Th1/Th2
- Medical subject headings
- Conjunctivitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beta-1,3-glucanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startJan 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Meiji University of Oriental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kyoto Prefectural University of Medicine
- Investigators
- Jun Yamada, M.D. Ph.D., Principal investigator, Meiji University of Oriental MedicineJunji Hamuro, Ph.D., Study director, Kyoto Prefectural University of MedicineShigeru Kinoshita, M.D. Ph.D., Study chair, Kyoto Prefectural University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276445
- Sponsor's protocol ID
- 15-58-2
- Other IDs
- Japanese Minis. Edu. 17791261
- Status last verified
- Jan 2004
- First submitted
- 12 Jan 2006
- Last updated
- 7 Nov 2006
- Results posted
- No
Publications
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.
PubMed 5768289
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan - A Double-Blind Randomized Study
- ClinicalTrials.gov ID
- NCT00276445
- Acronym / sponsor ID
- 15-58-2
- Conditions
- Allergic Conjunctivitis
- Keywords
- allergy, Allergy conjunctivitis, beta-1-3glucan, Th1/Th2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants
- Lead sponsor
- Meiji University of Oriental MedicineUniversity, hospital or other
- Collaborators
- Kyoto Prefectural University of Medicine
- Study start
- Jan 2004
- Study completion
- Jun 2004
- First posted
- 13 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who had undergone immunotherapy in the previous 5 years
- a history of other immunological or medically relevant diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beta-1,3-glucan | Drug | – |
Primary outcome
Symptoms were assessed clinically by score on a allergic symptom rating scale.
2 secondary outcomes
Total IgE and allergen specific IgE were measured.
The binding capacity of beta-1,3-glucan to peripheral CD14+ cells were assessed.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2006.
- Background: PubMed 5768289Chihara 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.
- Meiji University of Oriental MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Yamada, M.D. Ph.D. principal investigator
Meiji University of Oriental Medicine
Junji Hamuro, Ph.D. study director
Kyoto Prefectural University of Medicine
Shigeru Kinoshita, M.D. Ph.D. study chair
Kyoto Prefectural University of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing beta-1,3-glucan in people with Allergic Conjunctivitis, run by Meiji University of Oriental Medicine at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms were assessed clinically by score on a allergic symptom rating scale.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00276445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2006.