UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020957
Receipt number R000024162
Scientific Title A cross-sectional study evaluating prevalence of irritable bowel sydrome in the patients who undergo colonoscopy
Date of disclosure of the study information 2016/02/09
Last modified on 2016/05/08 20:41:34

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Basic information

Public title

A cross-sectional study evaluating prevalence of irritable bowel sydrome in the patients who undergo colonoscopy

Acronym

A cross-sectional study evaluating prevalence of IBS in the patients who undergo colonoscopy

Scientific Title

A cross-sectional study evaluating prevalence of irritable bowel sydrome in the patients who undergo colonoscopy

Scientific Title:Acronym

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



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

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

1st name
Middle name
Last name Fuyuki Akiko

Organization

Yokohama City University school of medicine

Division name

Department of gastroenterology and hepatology

Zip code


Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

045-787-2640

Email

fuyuki-sin@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Fuyuki Akiko

Organization

Yokohama City University school of medicine

Division name

Department of gastroenterology and hepatology

Zip code


Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

045-787-2640

Homepage URL


Email

fuyuki-sin@umin.ac.jp


Sponsor or person

Institute

Yokohama CIty University School of Medicine Department of Gastroenterology and Hepatology

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 09 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

2016 Year 02 Month 05 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024162


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name