UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of test food on period of testing positive for norovirus: a randomized, non-blinded trial.
Title of the study (Brief title)	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	Takeshi Ito
Organization	Incorporated Foundation Tokyo Kenbikyoin
Division name	Director Emeritus
Address	5-1, Toyomicho, Chuo-ku, Tokyo, Japan
TEL	03-3534-2970
Email	ito-t@umin.ac.jp

Public contact
Name of contact person	Takeshi Ito
Organization	Incorporated Foundation Tokyo Kenbikyoin
Division name	Director Emeritus
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 11 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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