UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028722 |
|---|---|
| Receipt number | R000024706 |
| Scientific Title | The survey of Helicobacter pylori infection rate and eradication therapy effect in Japanese junior high school students |
| Date of disclosure of the study information | 2017/08/18 |
| Last modified on | 2019/08/24 11:55:46 |
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Basic information
Public title
The survey of Helicobacter pylori infection rate and eradication therapy effect in Japanese junior high school students
Acronym
The survey of Helicobacter pylori infection rate and eradication therapy effect in Japanese junior high school students
Scientific Title
The survey of Helicobacter pylori infection rate and eradication therapy effect in Japanese junior high school students
Scientific Title:Acronym
The survey of Helicobacter pylori infection rate and eradication therapy effect in Japanese junior high school students
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the validity of introducing H. pylori infection test (urinary anti-H. pylori antibody test) to junior high school students and devote their significance. At the same time, for persons who are H. pylori-positive and desire sterilization, we verify the effectiveness and safety of eradication treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. H. pylori infection rate in Saga prefecture junior high school third graders, infection rate of each distinction
2. Success rate of eradication treatment in H. pylori eradication treatment (primary, secondary)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Presence or absence of Helicobacter pylori infection
Interventions/Control_2
Treatment for eradication of Helicobacter pylori
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
| 15 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Third grade junior high school student who got consent to the examination by the principal and the guardian for H.pylori test in Saga Prefecture
Key exclusion criteria
1. Person who did not obtain consent from the person himself / herself or a guardian
2. Person responsible for research, and those who judged that the attending physician has problems with participation
Target sample size
70000
Research contact person
Name of lead principal investigator
| 1st name | Muneaki |
| Middle name | |
| Last name | Matsuo |
Organization
Saga University Hospital
Division name
Pediatrics
Zip code
849-8501
Address
5-1-1 Nabeshima saga-City 849-8501 Japan
TEL
0952342314
matsuo@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Kimura |
Organization
Saga University Hospital
Division name
Clinical Research Center
Zip code
849-8501
Address
5-1-1 Nabeshima saga-City 849-8501 Japan
TEL
0952342314
Homepage URL
kenkyu-shinsei@ml.cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Saga Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Saga University Hospital
Address
5-1-1 Nabeshima, Saga, 849-8501 Japan
Tel
0952343400
kenkyu-shinsei@ml.cc.saga-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
| 2017 | Year | 08 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 18 | Day |
Last modified on
| 2019 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024706
