UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029761 |
|---|---|
| Receipt number | 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 | 2020/11/02 10:02:14 |
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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
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
sonare.since1192@gmail.com
Sponsor or person
Institute
National Centre for Global Health and Medicine
Institute
Department
Personal name
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
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
Completed
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
| 2020 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034004
