UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009240
Receipt number R000010851
Scientific Title Trial of Prevention of Irritable Bowel Syndrome by Smoking Cessation
Date of disclosure of the study information 2012/11/26
Last modified on 2016/11/13 23:09:31

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Basic information

Public title

Trial of Prevention of Irritable Bowel Syndrome by Smoking Cessation

Acronym

Smoking Cessation for IBS

Scientific Title

Trial of Prevention of Irritable Bowel Syndrome by Smoking Cessation

Scientific Title:Acronym

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

1st name
Middle name
Last name Shin Fukudo, MD, PhD

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Behavioral Medicine

Zip code


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

1st name
Middle name
Last name Shin Fukudo, MD, PhD

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Behavioral Medicine

Zip code


Address

2-1 Seiryo, Aoba, Sendai 980-8575 Japan

TEL

022-717-8214

Homepage URL


Email

sfukudo@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Graduate School of Medicine

Institute

Department

Personal name



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)



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

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


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

2012 Year 11 Month 26 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010851


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name