UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056295 |
|---|---|
| Receipt number | R000064325 |
| Scientific Title | Epidemiological Survey of Non-Helicobacter pylori Helicobacter Infection in Childhood |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2024/11/28 14:54:53 |
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Basic information
Public title
Epidemiological Survey of Non-Helicobacter pylori Helicobacter Infection in Childhood
Acronym
Epidemiological Survey of NHPH Infections in Childhood
Scientific Title
Epidemiological Survey of Non-Helicobacter pylori Helicobacter Infection in Childhood
Scientific Title:Acronym
Epidemiological Survey of NHPH Infections in Childhood
Region
| Japan |
Condition
Condition
NHPH Infections
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Infectious disease |
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the rate of NHPH infection in Japanese children, the rate of co-infection with H. pylori, and the factors that contribute to NHPH infection, in children aged 15 years or younger who are scheduled to undergo an upper gastrointestinal endoscopy and H. pylori infection diagnosis for screening or for abdominal symptoms such as anorexia and abdominal pain.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
NHPH infection rate in children under 15 years of age in Japan
Key secondary outcomes
1. Evaluation of the NHPH infection diagnosis method (real-time PCR method) using gastric juice in children
2. Evaluation of the patient background (age, sex, disease, pet ownership, history of hormone injections, etc.) of NHPH infection
3. Evaluation of abdominal symptoms of NHPH infection
4. Evaluation of endoscopic findings of NHPH infection
5. Co-infection rate of NHPH and H. pylori
6. H. pylori infection rate and NHPH infection rate by cause of endoscopy and symptoms
7. Relationship between severity and H. pylori infection by cause of endoscopy and symptoms
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
| Not applicable |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients who visit Oita University Hospital or one of the participating facilities and undergo an upper gastrointestinal endoscopy
(2) Patients who have given their consent to participate in this study, either verbally or in writing
(3) Patients who are under 15 years of age
Key exclusion criteria
(1) Cases where the patient has taken acid secretion inhibitors or antibacterial drugs within two weeks of the endoscopy
(2) Cases where the patient is taking immunosuppressant or steroid medication
(3) Cases where the patient has undergone surgical treatment of the esophagus or stomach
(4) Cases where the patient has a serious complication (heart failure, renal failure, hepatic failure, respiratory failure)
(5) Cases where the patient is judged to be unsuitable for participation in this study for other reasons
Target sample size
500
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
TEL
097-586-5401
sugimo@oita-u.ac.jp
Public contact
Name of contact person
| 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
TEL
097-586-5401
Homepage URL
sugimo@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Mitsushige Sugimoto
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | 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
| 2024 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special notes
Management information
Registered date
| 2024 | Year | 11 | Month | 28 | Day |
Last modified on
| 2024 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064325
