UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Epidemiology study about travelers' diarrhea in Japan using multiplex PCR
Title of the study (Brief title)	Epidemiology study about travelers' diarrhea in Japan
Region	Japan

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

Objectives
Narrative objectives1	to evaluate the pathogens of the TD using multiplex PCR-based detection.
Basic objectives2	Others
Basic objectives -Others	epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	to evaluate the pathogens of the TD using multiplex PCR-based detection.
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 12 January 2016 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	Satoshi Kutsuna
Organization	National Center for Global Health and Medicine
Division name	Disease Control and Prevention Center
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL	+81332027181
Email	skutsuna@hosp.ncgm.go.jp

Public contact
Name of contact person	Satoshi Kutsuna
Organization	National Centre for Global Health and Medicine
Division name	Disease Control and Prevention Center
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL	+81332027181
Homepage URL
Email	skutsuna@hosp.ncgm.go.jp

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)

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	2016 Year 05 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 12 Day
Anticipated trial start date	2016 Year 01 Month 12 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 11 Month 01 Day
Date trial data considered complete	2016 Year 11 Month 10 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	none

Management information
Registered date	2016 Year 05 Month 25 Day
Last modified on	2018 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023702