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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029761
Receipt No. R000034004
Scientific Title Epidemiology study about travelers' diarrhea in Japan using Verigene system
Date of disclosure of the study information 2017/10/30
Last modified on 2019/05/02

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Basic information
Public title Epidemiology study about travelers' diarrhea in Japan using Verigene system
Acronym Epidemiology study about travelers' diarrhea in Japan
Scientific Title Epidemiology study about travelers' diarrhea in Japan using Verigene system
Scientific Title:Acronym Epidemiology study about travelers' diarrhea in Japan
Region
Japan

Condition
Condition travellers' diarrhea
Classification by specialty
Medicine in general Gastroenterology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the pathogens of the TD using Verigene EP panel.
Basic objectives2 Others
Basic objectives -Others epidemiology
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes to evaluate the pathogens of the TD using Verigene EP panel.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who presented to NCGM between 13 February 2017 and 31 March 2018, and have diarrhea more than 3 times a day or more than 2 times a day with other associated symptoms.
Key exclusion criteria Patients who have diarrhea before trip.
Patients who have underlying illness with diarrhea.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name KUTSUNA
Organization National Center for Global Health and Medicine
Division name Disease Control and Prevention Center
Zip code 162-8655
Address Toyama
TEL +81332027181
Email sonare.since1192@gmail.com

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Kutsuna
Organization National Center for Global Health and Medicine
Division name Disease Control and Prevention Center
Zip code 162-8655
Address 1-21-1
TEL +81332027181
Homepage URL
Email sonare.since1192@gmail.com

Sponsor
Institute National Centre for Global Health and Medicine
Institute
Department

Funding Source
Organization National Centre for Global Health and Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Center for Global Health and Medicine
Address 1-21-1 Toyama, shiknjutu
Tel +81332027181
Email sonare.since1192@gmail.com

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 10 Month 30 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 102
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 No longer recruiting
Date of protocol fixation
2017 Year 01 Month 10 Day
Date of IRB
2017 Year 02 Month 13 Day
Anticipated trial start date
2017 Year 02 Month 13 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2017 Year 10 Month 30 Day
Last modified on
2019 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034004

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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