UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043933 |
|---|---|
| Receipt number | R000049776 |
| Scientific Title | Multicenter epidemiological study of Helicobacter pylori infection in dialysis patients |
| Date of disclosure of the study information | 2021/04/20 |
| Last modified on | 2022/10/26 11:10:11 |
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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
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
sannomiya-gif@umin.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049776
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
