UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Modification of Neurotransmission of Brain-Gut Interactions
Title of the study (Brief title)	Neuro-modification of Brain-Gut
Region	Japan

Condition
Condition	irritable bowel syndrome healthy controls
Classification by specialty	Medicine in general Gastroenterology Psychosomatic Internal Medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to test our hypothesis that brain-gut interactions in individuals with irritable bowel syndrome (IBS) is different from those in healthy controls.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	brain images of positron emission tomography (PET)
Key secondary outcomes	ordinate scale psychometric tests plasma/serum hormones

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	6
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	saline intravenous administration one time
Interventions/Control_2	CRH intravenous administration one time
Interventions/Control_3	alpha-helical CRH intravenous administration one time
Interventions/Control_4	ramosetron intravenous administration one time
Interventions/Control_5	naloxone intravenous administration one time
Interventions/Control_6	asimadoline intravenous administration one time
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Rome III/IV Asymptomatic healthy individual
Key exclusion criteria	organic diseases psychiatric diseases
Target sample size	240

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	022-717-8162
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	022-717-8162
Homepage URL
Email	sfukudo@med.tohoku.ac.jp

Sponsor
Institute	Department of Behavioral Medicine, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	JSPS/MEXT AMED/MHLW Institutional Grant
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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	2018 Year 04 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2010 Year 05 Month 01 Day
Anticipated trial start date	2010 Year 06 Month 01 Day
Last follow-up date	2022 Year 11 Month 30 Day
Date of closure to data entry	2022 Year 11 Month 30 Day
Date trial data considered complete	2022 Year 11 Month 30 Day
Date analysis concluded	2022 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 28 Day
Last modified on	2017 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034432