UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A cross-sectional study evaluating prevalence of irritable bowel sydrome in the patients who undergo colonoscopy
Title of the study (Brief title)	A cross-sectional study evaluating prevalence of IBS in the patients who undergo colonoscopy
Region	Japan

Condition
Condition	Irritable bowel syndrome
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the prevelance of irritable bowel syndorome in the patients who undergo standard colonoscopy.
Basic objectives2	Others
Basic objectives -Others	None
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The parcentage of patients with a diagnosis of irritable bowel syndrome using the ROME III criteria
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who undergo colonoscopy
Key exclusion criteria	Patients who refuse written informed concent
Target sample size	1000

Research contact person
Name of lead principal investigator	Fuyuki Akiko
Organization	Yokohama City University school of medicine
Division name	Department of gastroenterology and hepatology
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	045-787-2640
Email	fuyuki-sin@umin.ac.jp

Public contact
Name of contact person	Fuyuki Akiko
Organization	Yokohama City University school of medicine
Division name	Department of gastroenterology and hepatology
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	045-787-2640
Homepage URL
Email	fuyuki-sin@umin.ac.jp

Sponsor
Institute	Yokohama CIty University School of Medicine Department of Gastroenterology and Hepatology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Yokohama CIty University School of Medicine Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization	Self funding
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 02 Month 09 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 05 Day
Anticipated trial start date	2016 Year 02 Month 09 Day
Last follow-up date	2018 Year 03 Month 31 Day
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	The cross-sectional study We ask patients who undergo colonoscopy to answer the questionnaire of the ROMEIII criteria.

Management information
Registered date	2016 Year 02 Month 09 Day
Last modified on	2016 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024162