UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047303 |
|---|---|
| Receipt number | R000052538 |
| Scientific Title | Effect of a proton pump inhibitor on stool antigen tests for Helicobacter pylori infection |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/03/04 12:56:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of a proton pump inhibitor on stool antigen tests for Helicobacter pylori infection
Acronym
Effect of a proton pump inhibitor on stool antigen tests for Helicobacter pylori infection
Scientific Title
Effect of a proton pump inhibitor on stool antigen tests for Helicobacter pylori infection
Scientific Title:Acronym
Effect of a proton pump inhibitor on stool antigen tests for Helicobacter pylori infection
Region
| Japan |
Condition
Condition
Suspected H. pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study investigated effect of a proton pump inhibitor (PPI) on stool antigen tests for H. pylori infection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity of stool antigen tests (Quick Navi TM-H. pylori; Otsuka Pharmaceutical, Tokyo, Japan, Quick Chaser H. pylori; MIZUHO MEDY, Saga, Japan, BLEIA H. pylori Antigen; EIKEN CHEMICAL, Tokyo, Japan) before and after oral administration of a PPI (30 mg lansoprazole once daily for 14 days)
Key secondary outcomes
If not agreement, the stool antigen tests are reperformed at least 14 days after completing oral PPI administration
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Suspected H. pylori infection
Key exclusion criteria
1) Taking PPIs within 2 weeks of evaluating H. pylori infection
2) Taking antibiotics within 4 weeks of evaluating H. pylori infection
3) A previous history of gastrectomy
4) A previous history of H. pylori eradication therapy
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yusaku |
| Middle name | |
| Last name | Kajihara |
Organization
Fuyoukai Murakami Hospital
Division name
Department of Gastroenterology
Zip code
030-0843
Address
3-3-14 Hamada, Aomori, Japan
TEL
+81-17-729-8888
y_kaji2012@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yusaku |
| Middle name | |
| Last name | Kajihara |
Organization
Fuyoukai Murakami Hospital
Division name
Department of Gastroenterology
Zip code
030-0843
Address
3-3-14 Hamada, Aomori, Japan
TEL
+81-17-729-8888
Homepage URL
y_kaji2012@yahoo.co.jp
Sponsor or person
Institute
Fuyoukai Murakami Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding (Fuyoukai Murakami Hospital)
DENKA CO.,LTD.
MIZUHO MEDY CO.,LTD.
EIKEN CHEMICAL CO.,LTD.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fuyoukai Murakami Hospital
Address
3-3-14 Hamada, Aomori, Japan
Tel
+81-17-729-8888
y_kaji2012@yahoo.co.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
医療法人芙蓉会 村上病院（青森県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/hel.12961
Number of participants that the trial has enrolled
35
Results
The sensitivities and specificities before versus after PPI administration were as follows: 79.2% (19/24) and 100.0% (11/11) versus 75.0% (18/24) and 100.0% (11/11) for Quick Navi TM-H. pylori, respectively; 87.5% (21/24) and 100.0% (11/11) versus 75.0% (18/24) and 100.0% (11/11) for Quick Chaser H. pylori, respectively; 100.0% (24/24) and 100.0% (11/11) versus 95.8% (23/24) and 100.0% (11/11) for BLEIA H. pylori Antigen, respectively.
Results date posted
| 2022 | Year | 12 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 02 | Month | 24 | Day |
Baseline Characteristics
In this prospective study, 35 healthy Japanese subjects were enrolled.
Based on previous Japanese studies, an adequate number of subjects was determined to be at least 20 and 10 subjects with and without H. pylori infection, respectively.
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 25 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 25 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 14 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 24 | Day |
Other
Other related information
The study population is selected among hospital employees and outpatients.
Management information
Registered date
| 2022 | Year | 03 | Month | 28 | Day |
Last modified on
| 2023 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052538
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/09/15 | 改訂版）研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/09/15 | 改訂版）研究症例データ仕様書.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/03/05 | 研究症例データ.xlsx |
