UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Trial of Prevention of Irritable Bowel Syndrome by Smoking Cessation
Title of the study (Brief title)	Smoking Cessation for 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	Irritable bowel syndrome (IBS) is often evoked after the infectious gastroenteritis. Smoking is known as a risk factor of post-infectious IBS (PI-IBS). The aim of this study is to prevent individuals with infectious gastroenteritis from IBS by smoking cessation.
Basic objectives2	Others
Basic objectives -Others	Proving evidence that smoking is a causative factor of PI-IBS.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	IBS diagnosis
Key secondary outcomes	Number of cigarrete perceived stress scale (PSS)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Smoking cessation program based on cognitive behavior therapy
Interventions/Control_2	Control therapy (reading)
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	1) Use of the web. and 2) Subjects who suffers or suffered from acute infectious gastroenteritis in recent one month.
Key exclusion criteria	IBS subjects Patients with psychosis Patients with personality disorders
Target sample size	1200

Research contact person
Name of lead principal investigator	Shin Fukudo, MD, PhD
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Behavioral Medicine
Address	2-1 Seiryo, Aoba, Sendai 980-8575 Japan
TEL	022-717-8214
Email	sfukudo@med.tohoku.ac.jp

Public contact
Name of contact person	Shin Fukudo, MD, PhD
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Behavioral Medicine
Address	2-1 Seiryo, Aoba, Sendai 980-8575 Japan
TEL	022-717-8214
Homepage URL
Email	sfukudo@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Smoking Research Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	東北大学大学院医学系研究科

Other administrative information
Date of disclosure of the study information	2012 Year 11 Month 26 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 11 Month 26 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date
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

Management information
Registered date	2012 Year 11 Month 01 Day
Last modified on	2016 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010851