UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of GI tract function using rapid MRI
Title of the study (Brief title)	GI MRI functional assessment
Region	Japan

Condition
Condition	Gastrointestinal motility disorder
Classification by specialty	Medicine in general Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop analytical methods numerically extracting multidimensional features of gastrointestinal motility in MRI videos. The analytical methods may enable to combine information on gastrointestinal motility among institutions.
Basic objectives2	Others
Basic objectives -Others	Information regarding features of gastrointestinal motility by taking functional food, etc.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	To gain MRI analytical methods numerically and sensitively extracting multidimensional features of gastrointestinal motility (after assessment of applicability of various image analyses)
Key secondary outcomes	To reveal the influence of food to multidimensional gastrointestinal motility

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Commercial liquid meal (200 ml, 200 kcal) mixed with commercial oligo-saccharide (12g)
Interventions/Control_2
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) Adult male and female who understand the study plan and agree with a written informed consent 2) Unpaid participants recruited by poster display etc in the Hospital performing rapid MRI 3) Consideration of reward (approximately 1000 yen/hour) in case of shortage of participants
Key exclusion criteria	1) Those who are suspected unhealthy on the day of the MRI measurement 2) Those who do not understand the study plan, or those who disagree with a written informed consent
Target sample size	10

Research contact person
Name of lead principal investigator	Shinsuke Nakayama
Organization	Nagoya University
Division name	Graduate School of Medicine
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2045
Email	h44673a@nucc.cc.nagoya-u.ac.jp

Public contact
Name of contact person	Hidemi Teramoto
Organization	Kojin Hospital
Division name	Department of Internal Medicine
Address	1-710 Shikenya-cho, Moriyama-ku, Nagoya
TEL	052-771-2151
Homepage URL
Email	hteramoto@kojin-hospital.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Kojin Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nagoya University Graduate School of Medicine
Name of secondary funｄer(s)	R-Tech Corporation

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	絋仁病院（愛知県）、名古屋大学大学院医学系研究科（愛知県） (Kojin Hospital, Aichi; Nagoya University, Aichi)

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 21 Day
Anticipated trial start date	2018 Year 01 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
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=R000034424