UMIN-CTR Clinical Trial

Basic information
Public title	Study of Helicobacter pylori infection in dialysis patients
Acronym	Study of Helicobacter pylori infection in dialysis patients
Scientific Title	Multicenter epidemiological study of Helicobacter pylori infection in dialysis patients
Scientific Title:Acronym	Multicenter epidemiological study of Helicobacter pylori infection in dialysis patients
Region	Japan

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

Objectives
Narrative objectives1	To clarify the difference in the prevalence of H.pylori infection between patients with hemodialysis and normal renal function
Basic objectives2	Others
Basic objectives -Others	Study of the relationship between prevalence of H.pylori infection and duration of hemodialysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prevalence of H.pylori infection between patients with hemodialysis and normal renal function
Key secondary outcomes	Relationship between prevalence of H.pylori infection and duration of hemodialysis Prevalence of H.pylori infection in hemodialysis by age

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 on chronic hemodialysis with anti-H.pylori antibody or rapid urease test or H.pylori speculum examination will be the dialysis group. Patients with anti-H.pylori antibody or rapid urease test or H.pylori speculum examination and eGFR of 60 mL/min/1.73 m2 or higher in the human health checkup will be defined as the control group.
Key exclusion criteria	Patients who have received previous H. pylori eradication treatment or whose eradication history is unknown.Patients who have undergone rapid urease testing and are taking PPIs or mucosal protectants.
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Morita
Organization	Gifu University
Division name	Department of General Internal Medicine
Zip code	501-1194
Address	1-1 Yanagido, Gifu 501-1194, Japan
TEL	058-230-6632
Email	hmorita@gifu-u.ac.jp

Public contact
Name of contact person	1st name Noriko Middle name Last name Takahashi
Organization	Gifu University
Division name	Department of General Internal Medicine
Zip code	501-1194
Address	1-1 Yanagido, Gifu 501-1194, Japan
TEL	058-230-6632
Homepage URL
Email	sannomiya-gif@umin.ac.jp

Sponsor
Institute	Gifu University
Institute
Department

Funding Source
Organization	Gifu University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The ethics committee of the Gifu University Graduate School of Medicine
Address	1-1 Yanagido, Gifu 501-1194, Japan
Tel	058-230-6059
Email	rinri@gifu-u.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	2021 Year 04 Month 20 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	218
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Due to data analysis in progress
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	No longer recruiting
Date of protocol fixation	2021 Year 01 Month 29 Day
Date of IRB	2021 Year 03 Month 10 Day
Anticipated trial start date	2021 Year 03 Month 11 Day
Last follow-up date	2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study

Management information
Registered date	2021 Year 04 Month 15 Day
Last modified on	2022 Year 10 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049776