UMIN-CTR Clinical Trial

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
Email	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
Email	sfukudo@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004476