UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044949 |
|---|---|
| Receipt number | R000051352 |
| Scientific Title | Comparison of the improvement in gastric mucosal tissue after Helicobacter pylori eradication therapy between young and elderly people |
| Date of disclosure of the study information | 2021/07/25 |
| Last modified on | 2023/07/27 09:15:42 |
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Basic information
Public title
Comparison of the improvement in gastric mucosal tissue after Helicobacter pylori eradication therapy between young and elderly people
Acronym
Comparison of the improvement in gastric mucosal tissue after Helicobacter pylori eradication therapy between young and elderly people
Scientific Title
Comparison of the improvement in gastric mucosal tissue after Helicobacter pylori eradication therapy between young and elderly people
Scientific Title:Acronym
Comparison of the improvement in gastric mucosal tissue after Helicobacter pylori eradication therapy between young and elderly people
Region
| Japan |
Condition
Condition
Helicobacter pylori-associated gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigated the histological improvement in Helicobacter pylori eradication therapy for elderly people
Basic objectives2
Others
Basic objectives -Others
Histological change
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rates of histological cure and improvement in atrophy and intestinal metaplasia one year after Helicobacter pylori eradication in an elderly people and a younger people
Key secondary outcomes
The rates of histological cure and improvement in atrophy and intestinal metaplasia long term observation after Helicobacter pylori eradication in an elderly people and a younger people
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Age is 20 years or older at the time of consent acquisition
2) The elderly group is 70 years old or older at the time of sterilization, and the younger group is 45 years old or younger at the time of sterilization.
Key exclusion criteria
1) Cases in which consent was not obtained for this study
Target sample size
1017
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Mizukami |
Organization
Oita University
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1, idaigaoka, Hasama, Yufu, Oita
TEL
097-586-6193
mizkaz0809@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Mizukami |
Organization
Oita University
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1, idaigaoka, Hasama, Yufu, Oita
TEL
097-586-6193
Homepage URL
mizkaz0809@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Oita University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Oita University
Address
1-1, idaigaoka, Hasama, Yufu, Oita
Tel
097-586-6380
rinrikenkyu@oita-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 | 07 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
221
Results
In histological atrophy, higher rates of improvement were seen in the corpus than in the antrum, and the rates of cure in the antrum were lower in elderly group than in younger group (p = 0.0282). With regard to intestinal metaplasia, the rates of improvement in the antrum were lower in elderly group than in younger.
Results date posted
| 2023 | Year | 07 | Month | 27 | Day |
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
Main results already published
Date of protocol fixation
| 2020 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not particular
Management information
Registered date
| 2021 | Year | 07 | Month | 25 | Day |
Last modified on
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051352
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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