UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041890 |
|---|---|
| Receipt number | R000047814 |
| Scientific Title | Clinical usefulness of high-sensitivity stool H. pyroli antigen test using BLEIA method |
| Date of disclosure of the study information | 2020/09/25 |
| Last modified on | 2020/09/24 20:07:02 |
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Basic information
Public title
Clinical usefulness of high-sensitivity stool H. pyroli antigen test using BLEIA method
Acronym
BLEIA study
Scientific Title
Clinical usefulness of high-sensitivity stool H. pyroli antigen test using BLEIA method
Scientific Title:Acronym
BLEIA study
Region
| Japan |
Condition
Condition
H.Pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of acid secretion inhibitor on H. pylori stool antigen test (BLEIA method)
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison for sensitivity of H. pylori stool antigen test (BLEIA method) with or without oral acid secretion inhibitor
Key secondary outcomes
Comparison of H. Pylori stool antigen test (BLEIA method) post-eradication accuracy with or without acid secretion inhibitor
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who have been diagnosed as H. pirori positive and are planning eradication treatment
Key exclusion criteria
Penicillin allergy
Postoperative upper gastrointestinal tract
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Chika |
| Middle name | |
| Last name | Kusano |
Organization
Department of Medicine, Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
101-8309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
03-3293-1711
ckusano2007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Kusano |
Organization
Department of Medicine, Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
101-8309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
03-3293-1711
Homepage URL
ckusano2007@yahoo.co.jp
Sponsor or person
Institute
Department of Medicine, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
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
Nihon University Hospital
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
Tel
03-3293-1711
ckusano2007@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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2020 | Year | 09 | Month | 24 | Day |
Last modified on
| 2020 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047814
