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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02691637
Other study ID # B-0602/030-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2006
Est. completion date December 2022

Study information

Verified date April 2023
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Helicobacter pylori (H. pylori) infection has been associated with a development of atrophic gastritis and intestinal metaplasia. H. pylori related atrophic gastritis and intestinal metaplasia have been regarded as pre-malignant lesion. However, the role of H. pylori eradication treatment in the reversibility of atrophic gastritis and intestinal metaplasia has not been clearly defined. The aim of the present study was to investigate the relationship between H. pylori eradication and the reversibility of atrophic gastritis and intestinal metaplasia in Korean patients.


Description:

It is a prospective, case-control study to compare the status of atrophic gastritis and intestinal metaplasia from the patients who undergo H. pylori eradication treatment or not. After enrollment, each patient will be receive annual surveillance upper gastrointestinal endoscopy. The present investigators will monitor the status of atrophic gastritis and intestinal metaplasia annually and finally compare the reversibility of them.


Recruitment information / eligibility

Status Completed
Enrollment 1450
Est. completion date December 2022
Est. primary completion date January 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients who diagnosis of H. pylori infection - Patients presenting with H. pylori related gastrointestinal disease and/or - Patients do not have H. pylori related gastrointestinal disease. But, want H. pylori eradication Exclusion Criteria: - Age under 18 years Previous eradication treatment for H. pylori Patients who took any drug which could influence the study results such as proton pump inhibitor, antibiotics within 4 weeks History of gastrectomy Advanced gastric cancer or other malignancy Abnormal liver function or liver cirrhosis Abnormal renal function or chronic kidney disease Other severe concurrent diseases Previous allergic reactions to the study drugs Pregnant or lactating women

Study Design


Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi-do

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital National Clinical Research Coordination Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The improvement of Atrophic Gastritis and Intestinal metaplasia score The improvement of Atrophic Gastritis and Intestinal metaplasia was defined as improvement of score compared with baseline.
The histological features of the gastric mucosa were recorded using updated Sydney system scores, that is, 0 = none, 1 = mild, 2 = moderate, and 3 = marked.(Am J Surg Pathol 1996;20:1161-81.) Outcome measure will be done annually (per 1 year), final follow-up is 2019
per 1 year
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