UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037389 |
|---|---|
| Receipt number | R000042628 |
| Scientific Title | Improvement of malnutrition of dialysis patients by eradication of Helicobacter pylori |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2023/04/07 18:49:53 |
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Basic information
Public title
Improvement of malnutrition of dialysis patients by eradication of Helicobacter pylori
Acronym
Improvement of malnutrition of dialysis patients by eradication of Helicobacter pylori
Scientific Title
Improvement of malnutrition of dialysis patients by eradication of Helicobacter pylori
Scientific Title:Acronym
Improvement of malnutrition of dialysis patients by eradication of Helicobacter pylori
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation whether the nutritional status has been improved by eradication treatment for Helicobacter pylori-positive gastritis in dialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in BMI, geriatric nutritional risk index (GNRI), protein catabolism rate (nPCR), serum albumin, zinc concentration and carnitine concentration, before and after H. pylori eradication
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
Chronic kidney disease patients under dialysis treatment, who were examined the status of H. pylori infection.
Key exclusion criteria
cachectic state of malignancy
progressed liver dysfunction
pregnancy
stage 3-4 cardiac failure
active systemic infection
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Ushiogi |
Organization
Fukui-Saiseikai Hosp.
Division name
Nephrology
Zip code
918-8503
Address
Wadanaka-cho Funabashi 7-1 Fukui Pref. Japan
TEL
0776-23-1111
ushiogi.yasuyuki3001@fukui.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Ushiogi |
Organization
Fukui-Saiseikai Hosp.
Division name
Nephrology
Zip code
918-8503
Address
Wadanaka-cho Funabashi 7-1 Fukui Pref. Japan
TEL
0776-23-1111
Homepage URL
ushiogi.yasuyuki3001@fukui.saiseikai.or.jp
Sponsor or person
Institute
Fukui-Saiseikai Hosp.
Institute
Department
Personal name
Funding Source
Organization
Fukui-Saiseikai Hosp.
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
Hospital Ethics Review Board
Address
Wadanaka-cho Funabashi 7-1 Fukui Pref. Japan
Tel
0776-23-1111
shp@fukui.saiseikai.or.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
福井県
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 01 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Changes in BMI, geriatric nutritional risk index (GNRI), protein catabolism rate (nPCR), serum albumin, zinc concentration and carnitine concentration, before and after H. pylori eradication
Management information
Registered date
| 2019 | Year | 07 | Month | 16 | Day |
Last modified on
| 2023 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042628
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
