UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003697 |
|---|---|
| Receipt number | R000004476 |
| Scientific Title | Genomics and Neural Function in Irritable Bowel Syndrome |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2020/08/18 10:08:32 |
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Basic information
Public title
Genomics and Neural Function in Irritable Bowel Syndrome
Acronym
Neural Function in IBS
Scientific Title
Genomics and Neural Function in Irritable Bowel Syndrome
Scientific Title:Acronym
Neural Function in IBS
Region
| Japan |
Condition
Condition
irritable bowel syndorme
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to explore the factors which determines neural response to stimuli in controls and irritable bowel syndrome (IBS).
Basic objectives2
Others
Basic objectives -Others
Clarifying pathophysiology of IBS.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
brain imaging
Key secondary outcomes
symptoms
autonomic endocrine response
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
9
Purpose of intervention
Prevention
Type of intervention
| Medicine | Behavior,custom | Other |
Interventions/Control_1
no stimulus
Interventions/Control_2
mild stimulus
Interventions/Control_3
intense stimulus
Interventions/Control_4
conditioned stimulus
Interventions/Control_5
unconditioned stimulus
Interventions/Control_6
control intervention
Interventions/Control_7
behavioral intervention
Interventions/Control_8
placebo
Interventions/Control_9
agents that modifies stress response
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy controls
IBS diagnosed with Rome III criteria
Key exclusion criteria
serious organic disorder
serious psychiatric disorder
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Fukudo |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Behavioral Medicine
Zip code
980-8575
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 | Shin |
| Middle name | |
| Last name | Fukudo |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Behavioral Medicine
Zip code
980-8575
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
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Tohoku University Graduate School of Medicine
Address
2-1 Seiryo, Aoba, Sendai 980-8575, Japan
Tel
022-717-8007
med-kenkyo@bureau.tohoku.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2009-118/2015-1-084
Org. issuing International ID_1
Ethics Committee, Tohoku University Graduate School of Medicine
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
| 2010 | Year | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 02 | Day |
Last modified on
| 2020 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004476
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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