UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000024706