Community-based Helicobacter Pylori Eradication

November 12, 2012 updated by: National Taiwan University Hospital

Community-based Helicobacter Pylori Eradication With Two Sequential Antibiotic Regimens for the Residents and Migrants From a High-risk Area for Gastric Cancer

Based on a universal eradication of H. pylori in an offshore island (Matsu) with a high prevalence of gastric cancer as well as premalignant gastric lesion, we first examined the infection rate of H. pylori. Secondly, we evaluated the efficacy of clarithromycin-based triple therapy with a levofloxacin-based rescue treatment. And thirdly, we tested the hypothesis that whether the cure of H. pylori can reverse the premalignant gastric lesion. Fourth, we determine the cost-effectiveness of this intervention. The gene-environment interaction will be addressed regarding gastric cancer carcinogenesis. Finally, the incident rate of gastric cancer would be followed in this cohort.

Study Overview

Status

Unknown

Detailed Description

Despite the decline of global incidence, gastric cancer still affects public health substantially due to the considerable medical burden in the treatment of disease at the symptomatic stage. This fact has prompted clinicians to extend their attention from the multidisciplinary therapies to the design of preventive strategies. Gastric cancer development follows a carcinogenic process from non-atrophic gastritis, atrophic gastritis, intestinal metaplasia, dysplasia, and eventually to the adenocarcinoma. Helicobacter pylori (H. pylori) infection triggers this carcinogenic cascade and its eradication is currently the most reliable regimen to arrest the histologic progression in order to prevent gastric cancer. Emerging data have suggested that the benefit of H. pylori treatment earlier in the course of infection is larger and cannot be outweighed by a disfavored discount rate as a result of different time horizons between early treatment and later benefit of averting advanced cancer.

In the Asia-Pacific area, however, virulent strains of H. pylori infection are highly prevalent and premalignant gastric lesions may have already developed at the take-off age of active intervention. Our current knowledge remains limited in answering whether H. pylori eradication can regress these premalignant lesions and if so, what determinant can contribute to a positive response is unknown. The concept of "a point of no return" suggests that the benefit of H. pylori eradication may diminish at later stages when many types of molecular damage become irreversible. Several population-based studies, in contrast, found that the premalignant gastric lesions were potentially reversible given a sufficiently long duration free from infection. The inconsistence may reflect the facts that studies with adequate sample size and long enough follow-up are rarely available and that some important factors, such as the variation in host susceptibility to disease and dietary exposure to carcinogens, are difficult to be measured but they are likely to confound the results.

Therefore, the present study was to:

  1. Determine the efficacy of a novel regimen to treat the H. pylori infection in the general population.
  2. To address the question whether the premalignant gastric lesion could be reversed following the cure of infection.
  3. To simulate the cost-effectiveness of this chemoprevention.
  4. To use individual data to empirically calculate the cost-effectiveness of this intervention.
  5. To address the host genetic susceptibility to gastric cancer development.
  6. To follow-up the gastric cancer incidence following the eradication of H. pylori.

Study Type

Interventional

Enrollment (Anticipated)

5000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Taipei, Taiwan, 100
        • Completed
        • National Taiwan University Hospital
      • Taipei, Taiwan, 10015
        • Recruiting
        • Lee Yi-Chia
        • Contact:
        • Principal Investigator:
          • Jaw-Town Lin, MD, PhD
        • Principal Investigator:
          • Tony Hsiu-Hsi Chen, PhD

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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Helicobacter pylori infection subjects

Exclusion Criteria:

  • Prior gastrectomy; pregnant 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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: H pylori eradication
All enrolled subjects received chemoprevention with Helicobacter pylori eradication

For subjects who received the first-line treatment, the costs included the initial 13C-UBT, one-week triple therapy (esomeprazole 40mg once daily, amoxicillin 1g twice daily, and clarithromycin 500mg twice daily), and the confirmatory 13C-UBT. For subjects in whom the initial treatment failed, the costs further included the re-treatment consisting of ten-day triple therapy (esomeprazole 40mg once daily, amoxicillin 1g twice daily, and levofloxacin 500mg once daily), and the confirmatory 13C-UBT.

The first round of study was between 2004 and 2005, the second round was between 2008 and 2009, and the third round was between 2012 and 2013.

Other Names:
  • Chemoprevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful helicobacter eradication, change in premalignant gastric lesion, and change in gastric cancer incidence rate
Time Frame: 12 years
12 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Intragastric histologic change
Time Frame: 12 years
12 years

Collaborators and Investigators

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

Investigators

  • Study Chair: Pan-Chyr Yang, PHD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2004

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 12, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 940110

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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