UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Difference in prevalence of Helicobacter pylori infection in between patients with hemodialysis and normal renal function
Title of the study (Brief title)	Difference in prevalence of H.pylori infection in hemodialysis patients
Region	Japan

Condition
Condition	Helicobacter pylori infection
Classification by specialty	Gastroenterology Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the prevalence of Helicobacter pylori infection in between patients with hemodialysis and normal renal function.
Basic objectives2	Others
Basic objectives -Others	To compare the endoscopic finding in between patients with hemodialysis and normal renal function.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Prevalence of Helicobacter pylori infection in between hemodailysis group and normal renal function group.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who received a gastrointestinal endoscopy and rapid urease test or gastric mucosal biopsy for a diagnosis of Helicobacter pylori infection at Sato Hospital, between June, 2007 and December, 2013.
Key exclusion criteria	The criterion for the control group is the serum creatinine level less than 1.5 mg/dL.
Target sample size	400

Research contact person
Name of lead principal investigator	Hiroyuki Morita
Organization	Gifu University Graduate School of Medicine
Division name	Department of General Internal Medicine
Address	1-1 Yanagido, Gifu
TEL	058-230-6632
Email	hmorita@gifu-u.ac.jp

Public contact
Name of contact person	Noriko Takahashi
Organization	Gifu University Graduate School of Medicine
Division name	Department of General Internal Medicine
Address	1-1 Yanagido, Gifu
TEL	058-230-6632
Homepage URL
Email	dora_bokuemonn0427@yahoo.co.jp

Sponsor
Institute	Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
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 10 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 18 Day
Anticipated trial start date	2016 Year 10 Month 18 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	Performing a retrospective observational study based on the medical record information in patients who received a gastrointestinal endoscopy and rapid urease test or gastric mucosal biopsy at Sato hospital between January, 2007 and December, 2013.

Management information
Registered date	2016 Year 10 Month 18 Day
Last modified on	2016 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028148