UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endoscopic assessment based on the status of the Helicobacter pylori infection in patients with functional dyspepsia
Title of the study (Brief title)	Endoscopic assessment associated with Helicobacter pylori in functional dyspepsia
Region	Japan

Condition
Condition	Functional dyspepsia
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 elucidate the endoscopic findings in patients with functional dyspepsia (FD) based on the status of Helicobacter pylori infection.
Basic objectives2	Others
Basic objectives -Others	Detection of clinical characteristics
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Endoscopic findings which are mainly included in Kyoto classification of gastritis
Key secondary outcomes	The strength of upper gastrointestinal symptoms; reflux and dyspeptic symptoms The frequency of dyspeptic symptoms

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 who underwent esophagogastroduodenoscopy and wrote the questionnaire and informed consent.
Key exclusion criteria	The patients with serious disease (cancer, heart, lung, liver, and kidney disease) The patients with organic disease of upper gastrointestinal tract The patients with no consent The patients who underwent surgery of upper gastrointestinal tract The patients who have no assement after the eradication of Helicobacter pylori and the time of eradication is unclear
Target sample size	870

Research contact person
Name of lead principal investigator	Fumio TANAKA
Organization	Osaka City University Graduate School of Medicine
Division name	Gastroenterology
Address	1-4-3 Asahimachi, Abeno-ku, Osaka City, Osaka
TEL	06-6645-3811
Email	m2079981@med.osaka-cu.ac.jp

Public contact
Name of contact person	Fumio TANAKA
Organization	Osaka City University Graduate School of Medicine
Division name	Gastroenterology
Address	1-4-3 Asahimachi, Abeno-ku, Osaka City, Osaka
TEL	06-6645-3811
Homepage URL
Email	m2079981@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 24 Day
Anticipated trial start date	2016 Year 02 Month 24 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	Published
URL releasing results
Results
Other related information	Intern Med. 2018 Sep 12. doi: 10.2169/internalmedicine.1325-18. [Epub ahead of print]

Management information
Registered date	2016 Year 06 Month 14 Day
Last modified on	2018 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026188