- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02449941
Helicobacter Pylori and Proton Pump Inhibitor
December 4, 2016 updated by: Ji Yong Ahn, Asan Medical Center
Distribution of Helicobacter Pylori According to the Use of Proton Pump Inhibitor
The purpose of this study is to know the distribution of HP in stomach before use of PPI, during use of PPI, and after stop of PPI.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Endoscopy and biopsy will be performed to investigate the distrubition of HP before, during, and after using PPI.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Songpa-gu
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Seoul, Songpa-gu, Korea, Republic of, 138-736
- Asan Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Sample size will be determined based on the analysis the distribution rate of HP at first 30 patients.
Description
Inclusion Criteria:
- Patients who are indicated to endoscopic resection due to gastric neoplasm
- Aged between 19 to 65 years
- Informed consent
Exclusion Criteria:
- Previous history of HP eradication
- Previous history of PPI use within 6 months
- No HP infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Helicobacter pylori(HP) positive
Participants who are diagnosed with Helicobacter Pylori infection through ESD(endoscopic submucosal dissection) will be treated with PPI (proton pump inhibitor).
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Analysis the change of Helicobacter pylori distribution according to the use of proton pump inhibitor
Time Frame: Change in the distribution of Helicobacter Pylori(HP) at 4 months.
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Change in the distribution of Helicobacter Pylori(HP) at 4 months.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Analysis the change of HP distribution according to the use of PPI in atrophic change of stomach
Time Frame: Change in the distribution of Helicobacter Pylori(HP) at 4 months.
|
Change in the distribution of Helicobacter Pylori(HP) at 4 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ji Yong Ahn, Professor, Asan Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
May 14, 2015
First Submitted That Met QC Criteria
May 18, 2015
First Posted (Estimate)
May 21, 2015
Study Record Updates
Last Update Posted (Estimate)
December 6, 2016
Last Update Submitted That Met QC Criteria
December 4, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Helicobacter Infections
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Dexlansoprazole
- Lansoprazole
- Rabeprazole
- Pantoprazole
- Proton Pump Inhibitors
Other Study ID Numbers
- 2014-0341
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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