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NCT02449941 Clinical Trial

Helicobacter Pylori and Proton Pump Inhibitor

Helicobacter Infections Clinical Trial

Official title:
Distribution of Helicobacter Pylori According to the Use of Proton Pump Inhibitor

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02449941
Other study ID # 2014-0341
Secondary ID
Status Completed
Phase N/A
First received May 14, 2015
Last updated December 4, 2016
Start date March 2014
Est. completion date December 2016

Study information
Verified date December 2016
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Observational

Clinical Trial Summary

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.

Description:

Endoscopy and biopsy will be performed to investigate the distrubition of HP before, during, and after using PPI.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria:

1. Patients who are indicated to endoscopic resection due to gastric neoplasm

2. Aged between 19 to 65 years

3. Informed consent

Exclusion Criteria:

1. Previous history of HP eradication

2. Previous history of PPI use within 6 months

3. No HP infection

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• PPI (proton pump inhibitor)
Pre ESD (endoscopic submucosal dissection) Assessment atrophy and metaplasia in stomach, Check Helicobacter pylori Use of PPI for 2 months Post ESD 1 (After 2 months) Assess the distribution of helicobacter pylori after using PPI. Stop of PPI Post ESD 2 (After 4 months) Assess the distribution of helicobacter pylori after stop of PPI.

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul Songpa-gu

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Analysis the change of Helicobacter pylori distribution according to the use of proton pump inhibitor Change in the distribution of Helicobacter Pylori(HP) at 4 months. Yes
Secondary Analysis the change of HP distribution according to the use of PPI in atrophic change of stomach Change in the distribution of Helicobacter Pylori(HP) at 4 months. Yes
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