UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056543 |
|---|---|
| Receipt number | R000062809 |
| Scientific Title | Research on Non-Helicobacter pylori Helicobacter(NHPH) infecting the human stomach |
| Date of disclosure of the study information | 2024/12/25 |
| Last modified on | 2024/12/23 21:24:28 |
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Basic information
Public title
Research on Non-Helicobacter pylori Helicobacter(NHPH) infecting the human stomach
Acronym
Research on NHPH infecting the human stomach
Scientific Title
Research on Non-Helicobacter pylori Helicobacter(NHPH) infecting the human stomach
Scientific Title:Acronym
Research on NHPH infecting the human stomach
Region
| Japan |
Condition
Condition
Healthy subjects, gastric and duodenal ulcers, gastric MALT lymphoma, gastric cancer, gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will evaluate drug susceptibility testing for NHPH and conduct molecular epidemiological analysis using genomic information of NHPH strains.
Basic objectives2
Others
Basic objectives -Others
We will clarify the gastric bacterial flora and evaluate fecal and pathological diagnostic methods for NHPH infection.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Evaluation of drug susceptibility of NHPH
2. Identification of the infection route by genomic analysis of NHPH
Key secondary outcomes
1. Clarification of the bacterial species that infect the human stomach in NHPH infection
2. Evaluation of patient background (age, illness, history of keeping pets, etc.) of NHPH infection
3. Evaluation of endoscopic findings of NHPH infection
4. Evaluation of gastric bacterial flora in NHPH-infected patients
5. Evaluation of diagnostic methods for NHPH infection using blood, stool, gastric juice, culture, and tissue
6. Evaluation of gastritis in NHPH infection
7. Changes in the above tests after NHPH eradication
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) Those who visit Kyorin University Hospital and facilities participating in this research and undergo an upper gastrointestinal endoscopy as an insurance treatment or medical examination.
(2) The criteria for participation are (1) if the subject of the clinical trial "Fact-finding of Helicobacter spp. other than Helicobacter pylori that infects the human stomach" continues to participate, that is, if the subject suffers from gastroduodenal disease and tests positive for NHPH. Or 2) Those who are strongly suspected of having NHPH infection clinically and histologically and require detailed examination.
(3) Those who have given verbal and written consent to participate in this study.
Key exclusion criteria
(1) Persons who are unable to consent to participate in this study.
(2) Persons who lack the capacity to consent to this study.
(3) In the case of endoscopic biopsy, those who the attending physician judges to be prone to bleeding.
(4) Pregnant women and women who may be pregnant.
(5) Persons whose survival rate at the time of examination is less than 5 years.
(6) Persons with definite proof of Helicobacter pylori infection.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | KENGO |
| Middle name | |
| Last name | TOKUNAGA |
Organization
Kyorin University School of Medicine
Division name
Department of Preventive Medicine
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422475511
kentoku@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | KENGO |
| Middle name | |
| Last name | TOKUNAGA |
Organization
Kyorin University School of Medicine
Division name
Department of Preventive Medicine
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422475511
Homepage URL
kentoku@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokai University School of Medicine, Tokyo Medical University Hospital, Oita University School of Medicine, Hirosaki University Hospital, Kenwakai Hospital, Hakodate Medical Center, Aichi Medical University Hospital, Takeda Clinic, Kitasato University Hospital, Kayaba-cho Clinic, Public Interest Foundation Hokkaido Cancer Society, Kawasaki Medical School Hospital, Juntendo University Hospital, Keio University Hospital
Name of secondary funder(s)
Health and Labor Sciences Research Grant,MEXT,JSPS, Japanese Society of Helicobacter Research,
IRB Contact (For public release)
Organization
Kyorin University School of Medicine Research Ethics Committee
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
Tel
0422-47-5511
rec@ks.kyorin-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
21002
Org. issuing International ID_1
Japanese Society of Helicobacter Research
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
杏林大学医学部付属病院(東京都)、東海大学医学部付属病院(神奈川県)、東京医科大学病院(東京都)、大分大学医学部附属病院(大分県)、弘前大学医学部附属病院（青森県）、健和会病院(長野県)、函館医療センター（北海道）、愛知医科大学病院（愛知県）、武田医院(福岡県)、北里大学医学部 新世紀医療開発センター（神奈川県）、早期胃癌検診協会附属茅場町クリニック(東京都)、札幌がん検診センター（北海道）、川崎医科大学附属病院（岡山県）、順天堂大学医学部附属順天堂医院（東京都）、慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we will evaluate drug susceptibility tests for NHPH and perform molecular epidemiological analysis using genomic information of NHPH strains, which will enable us to propose antibiotics suitable for NHPH eradication treatment. Furthermore, molecular epidemiological analysis will enable us to clarify the infection route, propose methods to prevent NHPH infection, and propose new pathogenic factors of NHPH.
Management information
Registered date
| 2024 | Year | 12 | Month | 23 | Day |
Last modified on
| 2024 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062809
