UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033704 |
|---|---|
| Receipt number | R000038429 |
| Scientific Title | Study on the pathophysiology of diarrheal disease |
| Date of disclosure of the study information | 2018/08/14 |
| Last modified on | 2018/08/09 19:12:21 |
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Basic information
Public title
Study on the pathophysiology of diarrheal disease
Acronym
Study on the pathophysiology of diarrheal disease
Scientific Title
Study on the pathophysiology of diarrheal disease
Scientific Title:Acronym
Study on the pathophysiology of diarrheal disease
Region
| Japan |
Condition
Condition
Diarrheal disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the pathophysiology of diarrheal disease
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome is to characterize the microbiome of diarrheal disease
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
| 2 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible patients were Japanese with a diarrheal disease.
Key exclusion criteria
Exclusion criteria were: having significant acute or chronic coexisting illness; history of colectomy.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Nakajima |
Organization
Toho University Omori medical center
Division name
Department of General Medicine and Emergency Care
Zip code
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
0337624151
nakaji_ma521@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Nakajima |
Organization
Toho University Omori medical center
Division name
Department of General Medicine and Emergency Care
Zip code
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
0337624151
Homepage URL
nakaji_ma521@yahoo.co.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
東邦大学医療センター大森病院、大森敏秀胃腸科クリニック
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Between March 2017 and March 2020, we are recruiting diarrhea patients and healthy participants. We will analyze fecal microbiome and clarify the difference.
Management information
Registered date
| 2018 | Year | 08 | Month | 09 | Day |
Last modified on
| 2018 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038429
