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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028722
Receipt No. 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

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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
Email 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
Email kenkyu-shinsei@ml.cc.saga-u.ac.jp

Sponsor
Institute Saga University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024706

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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