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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028721
Receipt No. R000032870
Scientific Title Study of intestinal bacterial flora of H. pylori-infected person and non-infected person and relation with basic disease
Date of disclosure of the study information 2017/08/18
Last modified on 2019/08/24

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Basic information
Public title Study of intestinal bacterial flora of H. pylori-infected person and non-infected person and relation with basic disease
Acronym Study of intestinal bacterial flora with or without H.pylori infection
Scientific Title Study of intestinal bacterial flora of H. pylori-infected person and non-infected person and relation with basic disease
Scientific Title:Acronym Study of intestinal bacterial flora with or without H.pylori infection
Region
Japan

Condition
Condition Helicobacter pylori infection
Classification by specialty
Gastroenterology Child
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To analyze fecal matter of people infected with Helicobacter pylori infection (before eradication treatment) in third grade junior high school students in Saga prefecture and feces of uninfected persons, and investigate the difference between the microbial flora and the relation with each underlying disease.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between H. pylori infection and intestinal flora
Relationship between H. pylori infection and underlying disease
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
Other
Interventions/Control_1 Among the middle school third grader in Saga prefecture, we define that negative groups are negative in urinary anti-H. pylori infection examination. For fecal specimens provided by these subjects, a comprehensive analysis of the intestinal microflora is performed using the next generation sequencer.
Interventions/Control_2 Among the middle school third grader in Saga prefecture, we define that positive groups are positive for primary examination and also positive for H. pylori antigen test in feces. For fecal specimens provided by these subjects, a comprehensive analysis of the intestinal microflora is performed using the next generation sequencer.
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 Urinary anti-H. pylori antibody test recipient In Saga Prefecture's commissioned project "Promotion of Stomach Cancer Measures for the Future"
Key exclusion criteria 1. Persons who were unable to obtain consent from the person or guardian
2. Person who is responsible for research, and who is in the hospital, judged that the attending physician has problems in participation
3. Those who have already taken H. pylori eradication treatment
Target sample size 160

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-Cuty 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 Pediatrics
Zip code 849-8501
Address 5-1-1 Nabeshima saga-Cuty 849-8501 Japan
TEL 0952342314
Homepage URL
Email kakiucht@cc.saga-u.ac.jp

Sponsor
Institute Saga University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Biofermin Seiyaku Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Division of Clinical Research Center, Saga University
Address 5-1-1 Nabeshima, Saga, 849-8501 Japan
Tel 0952-34-3400
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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 149
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 Completed
Date of protocol fixation
2017 Year 03 Month 23 Day
Date of IRB
2017 Year 03 Month 23 Day
Anticipated trial start date
2017 Year 03 Month 23 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 07 Month 31 Day

Other
Other related information Distribute the personal information confirmation slip at the time of submitting the fecal specimen for intestinal bacterial flora and receive information. The contents include the name, date of birth, parental name, address, telephone number, name of the disease being diagnosed, current internal medicine, nutrition at infancy, presence or absence of collective childcare before preschool, family composition.

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=R000032870

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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