UMIN-CTR Clinical Trial

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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