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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016804
Receipt No. R000019505
Scientific Title An epidemiologic study of irritable bowel syndrome; multicenter study in Japan
Date of disclosure of the study information 2015/03/15
Last modified on 2017/03/21

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Basic information
Public title An epidemiologic study of irritable bowel syndrome; multicenter study in Japan
Acronym An epidemiologic study of IBS
Scientific Title An epidemiologic study of irritable bowel syndrome; multicenter study in Japan
Scientific Title:Acronym An epidemiologic study of IBS
Region
Japan

Condition
Condition irritable bowel syndrome
Classification by specialty
Medicine in general Gastroenterology Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the patient's background of IBS
Basic objectives2 Others
Basic objectives -Others The purpose of this study is to clarify the clinical features of IBS
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The purpose of this study is to clarify the patient's background of IBS
Key secondary outcomes To evaluate as follows;
1)Risk factor for severe IBS
2)Gender difference of IBS
3)Therapeutic course of IBS
4)Association between menstrual cramps and IBS
5)Association between pregnancy, parturition and IBS
6)Influence of proton pump inhibitor to IBS
7)Consultation rate of endoscopy in IBS patient
8)Association between obesity and IBS
9)Comparison of the clinical features of patient with IBS in clinic and flagship hospital
10)Association between subtype of IBS and QOL

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
15 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1)Outpatient suffering from irritable bowel syndrome
2)With informed consent obtained before participation
Key exclusion criteria 1)Subjects who were recognized unsuitable for this study by the investigator
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Yamada
Organization Saiseikai Yokohamashi Nanbu Hospital
Division name Gastroenterology
Zip code
Address 3-2-10 Kounandai Kounan-ku, Yokohama City, Kanagawa, Japan
TEL 045-832-1111
Email yamadae@nanbu.saiseikai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Yamada
Organization Saiseikai Yokohamashi Nanbu Hospital
Division name Gastroenterology
Zip code
Address 3-2-10 Kounandai Kounan-ku, Yokohama City, Kanagawa, Japan
TEL 045-832-1111
Homepage URL
Email yamadae@nanbu.saiseikai.or.jp

Sponsor
Institute Saiseikai Yokohamashi Nanbu Hospital
Institute
Department

Funding Source
Organization Saiseikai Yokohamashi Nanbu Hospital
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
2015 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/27129979
Number of participants that the trial has enrolled
Results
Lower MCS and female sex were risk factors for poor therapeutic response in patients with IBS. 
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 Completed
Date of protocol fixation
2015 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2015 Year 11 Month 01 Day
Date analysis concluded
2016 Year 01 Month 01 Day

Other
Other related information n/a

Management information
Registered date
2015 Year 03 Month 15 Day
Last modified on
2017 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019505

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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