UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028721 |
|---|---|
| Receipt number | 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 11:41:37 |
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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
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
kakiucht@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032870
