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

NCT02691637 | Completed

• 1 other identifier: B-0602/030-001
• Study Type: observational
• Target: 1,450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection; Atrophic Gastritis; Intestinal Metaplasia

Keywords

Helicobacter pylori infection; Eradication treatment; Reversibility; atrophic gastritis; intestinal metaplasia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• National Clinical Research Coordination Center, Seoul, Korea: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Officials Officials, Officials

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 14, 2016
• First Posted: February 25, 2016
• Study Start: February 1, 2006
• Primary Completion: January 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)