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Community-Based Helicobacter Pylori Eradication
This study has been completed.
First Received: September 8, 2005   Last Updated: May 17, 2009   History of Changes
Sponsor: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00155389
  Purpose

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.


Condition Intervention Phase
Helicobacter Pylori Infection
Drug: esomeprazole, amoxicillin, clarithromycin, levofloxacin
Drug: Helicobacter pylori eradication
Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Community-Based Helicobacter Pylori Eradication With Two Sequential Antibiotic Regimens for the Residents and Migrants From a High-Risk Area for Gastric Cancer

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Successful helicobacter eradication, change in premalignant gastric lesion, and change in gastric cancer incidence rate [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intragastric histologic change [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 4784
Study Start Date: January 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: esomeprazole, amoxicillin, clarithromycin, levofloxacin
    For subjects who received the first-line treatment, the intervention 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 intervention 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.
    Drug: 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.
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.
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Helicobacter pylori infection subjects

Exclusion Criteria:

  • Prior gastrectomy; pregnant women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00155389

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Lee Yi-Chia
Taipei, Taiwan, 10015
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Pan-Chyr Yang, PHD National Taiwan University Hospital
  More Information

Additional Information:
Publications:
Responsible Party: National Taiwan University Hospital ( National Taiwan University Hospital )
Study ID Numbers: 940110
Study First Received: September 8, 2005
Last Updated: May 17, 2009
ClinicalTrials.gov Identifier: NCT00155389     History of Changes
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Helicobacter pylori
Gastric cancer
single nucleotide polymorphism

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Ofloxacin
Omeprazole
Infection
Renal Agents
Clarithromycin
Anti-Bacterial Agents
Stomach Diseases
Neoplasms by Site
Stomach Neoplasms
Therapeutic Uses
Anti-Ulcer Agents
Nucleic Acid Synthesis Inhibitors
Amoxicillin
Digestive System Neoplasms
Gastrointestinal Agents
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Pharmacologic Actions
Protein Synthesis Inhibitors
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010