UMIN-CTR Clinical Trial

Basic information
Public title	Comprehensive assessment of the association between exosome-derived miRNA expression in gastric juice and functional dyspepsia
Acronym	Exosome-derived miRNA expressions in gastric juice of functional dyspepsia patients
Scientific Title	Comprehensive assessment of the association between exosome-derived miRNA expression in gastric juice and functional dyspepsia
Scientific Title:Acronym	Exosome-derived miRNA expressions in gastric juice of functional dyspepsia patients
Region	Japan

Condition
Condition	Functional dyspepsia
Classification by specialty	Medicine in general Gastroenterology Psychosomatic Internal Medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The aim of this study is to identify the specific exosome-derived miRNA expression in gastric juice of fuctional dyspepsia patients.
Basic objectives2	Others
Basic objectives -Others	The analysis of pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The expression of exosome-derived miRNA in gastric juice
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients underwent esophagogastroduodenoscopy and analysis of anti-Helicobacter pylori (H.pylori) IgG antibody. The patients who wrote questionaire and informed consent.
Key exclusion criteria	The patients who have severe diseases of heart, lung, liver, kidney, thyroid, mental, and cancer. The patients who have organic diseases of upper gastrointestinal tract; gastric and duodenal ulcer, gastric cancer and adenoma The patients who had history of operarion in abdomen The patients who take anti-acid drugs The patients who take NSAIDs The patients who take anti-coagulants The patients who did not have assement of H.pylori eradication The patients who had unknown history of H.pylori eradication H.pylori IgG showed false-negative
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Fumio Middle name Last name TANAKA
Organization	Osaka City University Graduate School of Medicine
Division name	Gastroenterology
Zip code	5458585
Address	1-4-3 Asahimachi, Abeno-ku, Osaka City, Osaka
TEL	0666453811
Email	m2079981@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Fumio Middle name Last name TANAKA
Organization	Osaka City University Graduate School of Medicine
Division name	Gastroenterology
Zip code	5458585
Address	1-4-3 Asahimachi, Abeno-ku, Osaka City, Osaka
TEL	0666453811
Homepage URL
Email	m2079981@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka City University Hospital Certified Review Board
Address	Abeno Medix 6F, 1-2-7, Asahimachi, Abeno-ku, Osaka
Tel	06-6646-6125
Email	ethics@med.osaka-cu.ac.jp

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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 21 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	22
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	Completed
Date of protocol fixation	2016 Year 04 Month 20 Day
Date of IRB	2016 Year 05 Month 30 Day
Anticipated trial start date	2016 Year 04 Month 20 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The results of this study was published.

Management information
Registered date	2016 Year 06 Month 21 Day
Last modified on	2020 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026308