UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062406 |
|---|---|
| Receipt number | R000071419 |
| Scientific Title | Clinical importance of Helicobacter suis infection and gastric microbiota in patients received medical health check-ups: An International collaborative prospective observational study |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/07/30 13:58:08 |
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Basic information
Public title
Clinical importance of Helicobacter suis infection and gastric microbiota in patients received medical health check-ups:
An International collaborative prospective observational study
Acronym
Clinical importance of H. suis infection and gastric microbiota:
An International collaborative prospective observational study
Scientific Title
Clinical importance of Helicobacter suis infection and gastric microbiota in patients received medical health check-ups:
An International collaborative prospective observational study
Scientific Title:Acronym
Clinical importance of H. suis infection and gastric microbiota:
An International collaborative prospective observational study
Region
| Japan | Asia(except Japan) |
Condition
Condition
H. suis infectious disease
Classification by specialty
| Medicine in general | Gastroenterology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was designed to compare the prevalence of H. suis infection in Japan and Korea among individuals received endoscopy. The study aims to identify factors contributing to H. suis infection, clarify its association with the development of GI diseases, and investigate its relationship with the gastric microbiota through an international, multicenter, prospective study.
Basic objectives2
Others
Basic objectives -Others
Etiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Comparison of H. suis infection rates between Koreans and Japanese who underwent endoscopy as health check-ups
(2) Comparison of gastric microbiome profiles between H. suis-positive and H. suis-negative groups
Key secondary outcomes
(1) To identify the characteristics of H. suis-infected individuals in Korea and Japan
(2) To investigate the association between H. suis infection and pet ownership history, pet type, and duration of ownership in Korea and Japan
(3) To investigate the association between H. suis infection and a history of consuming pig offal and other specific foods in Korea and Japan
(4) To demonstrate the accuracy of methods (ELISA and PCR) for detecting H. suis infection in Korean population
(5) To identify endoscopic characteristics of H. suis-infected patients in Koreans and Japanese
(6) To identify associations between H. suis infection and abdominal symptoms in Koreans and Japanese
(7) To identify infection rates by type of NHPH in Koreans and Japanese
(8) To clarify the association between H. suis infection and GI diseases in Koreans and Japanese
(9) To clarify differences in gastric microbiome profiles between H. suis-positive and -negative groups in Koreans and Japanese
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Individuals aged 20 or older who scheduled to receive an EGD for check-ups by March 31, 2028
(2) Individuals who have provided written informed consent to participate
Key exclusion criteria
(1) Individuals whose H. pylori infection status is unknown
(2) Individuals who have had gastric surgical treatment
(3) Individuals who have taken antimicrobial agents within two weeks
(4) Individuals whom the research staff deem unsuitable
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Mitsushige |
| Middle name | |
| Last name | Sugimoto |
Organization
Oita University
Division name
Research Center for GLOBAL and LOCAL Infectious Disease
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama, Yufu, Oita
TEL
+81-97-586-6223
sugimo@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsushige |
| Middle name | |
| Last name | Sugimoto |
Organization
Oita Universit
Division name
Research Center for GLOBAL and LOCAL Infectious Disease
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama, Yufu, Oita
TEL
+81-97-586-6223
Homepage URL
sugimo@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Oita University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita University Faculty of Medicine Ethics Committee
Address
1-1 Idaigaoka, Hasama, Yufu
Tel
097-586-5157
rinrikenkyu@oita-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
日本 (7施設): 北海道対がん協会 (北海道)、青森県総合健診センター (青森県)、東京医科大学病院 健診予防医学センター (東京都)、杏林大学医学部付属病院 予防医学センター(東京都)、京都医療センター(京都府)、川崎医科大学総合医療センター(岡山県)、花牟禮病院(鹿児島県)
韓国(2施設): Inchon St. Mary's Hospital, The Catholic University of Korea, St. Vincent's Hospital, The Catholic University of Korea
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
type of information: medical records, medical history, questionnaire data
1. abdominal symptoms: gsrs questionnaires
2. patients background:
race, age, gender, smoking history, drinking history, height, weight,
medical history, family history, history of international travel,
history of medication use
religion, educational background, area of residence,
dental history,
contact with animals. H. pylori: history of test and eradication therapy, number of eradication, year of treatment
4. pet ownership history: type of pet, number of pets owned, duration of ownership, and interaction patterns
5. history eating offal: presence, frequency, animal species
6. history eating game meat: presence, frequency, animal species
7. blood test results
8. pathology findings: inflammatory cell infiltration or atrophy
9. H. suis infection information: based on ELISA and PCR test results
10. gastric microbiota profile
Management information
Registered date
| 2026 | Year | 07 | Month | 30 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071419
