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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030089
Receipt No. R000034349
Scientific Title Effect of test food on period of testing positive for norovirus: a randomized, non-blinded trial.
Date of disclosure of the study information 2017/11/24
Last modified on 2018/10/17

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Basic information
Public title Effect of test food on period of testing positive for norovirus: a randomized, non-blinded trial.
Acronym Effect of test food on period of testing positive for norovirus: a randomized, non-blinded trial.
Scientific Title Effect of test food on period of testing positive for norovirus: a randomized, non-blinded trial.
Scientific Title:Acronym Effect of test food on period of testing positive for norovirus: a randomized, non-blinded trial.
Region
Japan

Condition
Condition Norovirus gastroenteritis
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effect of test food on period of testing positive for norovirus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Period of testing positive for norovirus
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of test food (maximum of 21 days)
Interventions/Control_2 Non-ingestion of test food
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 1) Aged 20 and above
2) Testing positive for norovirus
Key exclusion criteria 1) Subjects in pregnancy or breast-feeding
2) Subjects with milk allergy
3) Subjects who consume test food habitually
4) Subjects who have a history of serious disorders in liver, kidney, heart, lung, gastro-intestine, blood, endocrine system, or metabolic system etc.
5) Subjects who are judged inappropriate to this trial by the investigator
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Ito
Organization Incorporated Foundation Tokyo Kenbikyoin
Division name Director Emeritus
Zip code
Address 5-1, Toyomicho, Chuo-ku, Tokyo, Japan
TEL 03-3534-2970
Email ito-t@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Ito
Organization Incorporated Foundation Tokyo Kenbikyoin
Division name Director Emeritus
Zip code
Address 5-1, Toyomicho, Chuo-ku, Tokyo, Japan
TEL 03-3534-2970
Homepage URL
Email ito-t@umin.ac.jp

Sponsor
Institute Incorporated Foundation Tokyo Kenbikyoin
Institute
Department

Funding Source
Organization Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 24 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
2017 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 22 Day
Last modified on
2018 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034349

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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