Effect of H. Pylori Eradication on the Reversibility of Atrophic Gastritis and Intestinal Metaplasia in Korean Patients

April 16, 2023 updated by: Nayoung Kim, Seoul National University Bundang Hospital

Effect of Helicobacter Pylori Eradication on the Reversibility of Atrophic Gastritis and Intestinal Metaplasia in Korean Patients.

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1450

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

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of
        • Seoul National University Bundang Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who have H. pylori related gastrointestinal disease and/or Patients who do not have H. pylori related gastrointestinal disease. But, want H. pylori eradication

Description

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 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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
H. pylori eradication group
Patients who have had H. pylori infection. After diagnosis of H. pylori infection, the patients who subsequently received successful H. pylori eradication treatment according to appropriate indication.
Control Group
Patients who still have H. pylori infection. The patients of control group do not have successful H. pylori eradication result or do not received eradication treatment for any reason.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The improvement of Atrophic Gastritis and Intestinal metaplasia score
Time Frame: per 1 year

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

National Clinical Research Coordination Center, Seoul, Korea

Investigators

  • Principal Investigator: Officials Officials, Officials, Seoul National University Bundang Hospital

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

February 1, 2006

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

February 14, 2016

First Submitted That Met QC Criteria

February 20, 2016

First Posted (Estimate)

February 25, 2016

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 16, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-0602/030-001

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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