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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020660
Receipt No. R000023847
Scientific Title The potential of beta-glucan intake in the prevention of viral diseases.
Date of disclosure of the study information 2016/01/25
Last modified on 2016/03/01

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Basic information
Public title The potential of beta-glucan intake in the prevention of viral diseases.
Acronym The potential of beta-glucan intake in the prevention of viral diseases.
Scientific Title The potential of beta-glucan intake in the prevention of viral diseases.
Scientific Title:Acronym The potential of beta-glucan intake in the prevention of viral diseases.
Region
Japan

Condition
Condition influenza and norovirus-related gastroenteritis
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the potential of daily intake of beta-glucan for the prevention of influenza and norovirus-related gastroenteritis in elderly patients in long-term care hospitals.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Whether or not the patient develops influenza and/or norovirus-related gastroenteritis within 6 months after beginning the trial
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 The participants ingest 50mg of beta-glucan twice a day for 6 months via either a naso-gastric tube, gastric fistula or intestinal fistula.
Interventions/Control_2 No treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients receiving nutrition via naso-gastric tube, gastric fistula or intestinal fistula at a long-term care hospital
Key exclusion criteria Patients whose condition is unstable
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunji Mizobuchi
Organization Kochi Medical School, Kochi University
Division name Clinical Nursing
Zip code
Address Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL 088-866-5811
Email mizoshun@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunji Mizobuchi
Organization Kochi Medical School, Kochi University
Division name Clinical Nursing
Zip code
Address Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL 088-880-2564
Homepage URL
Email mizoshun@kochi-u.ac.jp

Sponsor
Institute Kochi University
Institute
Department

Funding Source
Organization NST Beta・Glucan Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 医療法人 仁泉会 朝倉病院(高知県)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2016 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 25 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 20 Day
Last modified on
2016 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023847

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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