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
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
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
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
