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

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 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

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

Value
https://center6.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