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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name