UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the pathophysiology of diarrheal disease
Title of the study (Brief title)	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	Hitoshi Nakajima
Organization	Toho University Omori medical center
Division name	Department of General Medicine and Emergency Care
Address	6-11-1 Omorinishi, Ota-ku, Tokyo
TEL	0337624151
Email	nakaji_ma521@yahoo.co.jp

Public contact
Name of contact person	Hitoshi Nakajima
Organization	Toho University Omori medical center
Division name	Department of General Medicine and Emergency Care
Address	6-11-1 Omorinishi, Ota-ku, Tokyo
TEL	0337624151
Homepage URL
Email	nakaji_ma521@yahoo.co.jp

Sponsor
Institute	Toho University
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038429