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OpenTrials
Completed

NCT Number: NCT02691637

Effect of H. 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • National Clinical Research Coordination Center, Seoul, Korea

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2016
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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