CClinicalTrials.gg
CompletedNCT02691637Updated Apr 18, 2023

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

An observational study in Helicobacter Pylori Infection, Atrophic Gastritis and Intestinal Metaplasia, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by Seoul National University Bundang Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,450
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Helicobacter Pylori Infection
  • Atrophic Gastritis
  • Intestinal Metaplasia

Keywords

  • Helicobacter pylori infection
  • Eradication treatment
  • Reversibility
  • atrophic gastritis
  • intestinal metaplasia
03

In context

Gastritis

196 studies on the registry are indexed under Gastritis; 42 are open to participants now.

This study's enrollment of 1,450 is above the median of 400 across 79 observational studies indexed under Gastritis.

Browse Gastritis studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,450 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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

    Time frame: per 1 year

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam, Gyeonggi-do, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02691637
Lead sponsor
Seoul National University Bundang Hospital
Collaborators
National Clinical Research Coordination Center, Seoul, Korea
Responsible party
Nayoung Kim (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Feb 25, 2016
Start date
Feb 2006
Primary completion
Jan 2022
Completion
Dec 2022
Last update
Apr 18, 2023

Study contacts

Officials Officials, Officials
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion