UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Helicobacter pylori eradication therapy for the junior high school students
Title of the study (Brief title)	Helicobacter pylori eradication therapy for the junior high school students.
Region	Japan

Condition
Condition	Helicobacter pylori infection
Classification by specialty	Gastroenterology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Helicobacter pylori eradication for junior high school student
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Success rate of helicobacter pylori eradication for junior high school student
Key secondary outcomes	The incidence of side effect through the helicobacter pylori eradication for junior high school student The change of micro biome before and after the eradication therapy in children

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Eradication therapy for Helicobacter pylori
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	12 years-old <=
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	Helicobacter pyroli infection
Key exclusion criteria	Students or their parents refuse the eradication therapy. Student who have an allergy to medicine. Student who is less than 40 kg in weght.
Target sample size	100

Research contact person
Name of lead principal investigator	Chika Kusano
Organization	Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine
Division name	Gastroenterology & Hepatology
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL	03-3293-1711
Email	ckusano2007@yahoo.co.jp

Public contact
Name of contact person	Chika Kusano
Organization	Department of Medicine, Nihon University School of Medicine
Division name	Gastroenterology & Hepatology
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL	03-3293-1711
Homepage URL
Email	ckusano2007@yahoo.co.jp

Sponsor
Institute	Yurihonjyo and Nikaho city
Institute
Department

Funding Source
Organization	Yurihonjyo and Nikaho city
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	JA秋田厚生連由利組合総合病院

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 13 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 03 Month 27 Day
Anticipated trial start date	2015 Year 06 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 13 Day
Last modified on	2019 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020737