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Community-based Helicobacter Pylori Eradication

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ClinicalTrials.gov Identifier: NCT00155389
Recruitment Status : Unknown
Verified July 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Helicobacter pylori eradication Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2004
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Active Comparator: H pylori eradication
All enrolled subjects received chemoprevention with Helicobacter pylori eradication
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.

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 Name: Chemoprevention




Primary Outcome Measures :
  1. Successful helicobacter eradication, change in premalignant gastric lesion, and change in gastric cancer incidence rate [ Time Frame: 12 years ]

Secondary Outcome Measures :
  1. Intragastric histologic change [ Time Frame: 12 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Helicobacter pylori infection subjects

Exclusion Criteria:

  • Prior gastrectomy; pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00155389


Contacts
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Contact: Pan-Chyr Yang, PHD 886-2-2356-2000 pcyang@ha.mc.ntu.edu.tw

Locations
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Taiwan
Lee Yi-Chia Recruiting
Taipei, Taiwan, 10015
Contact: Yi-Chia Lee, MD, MSc    23123456 ext 63351    yichialee@ntu.edu.tw   
Principal Investigator: Jaw-Town Lin, MD, PhD         
Principal Investigator: Tony Hsiu-Hsi Chen, PhD         
National Taiwan University Hospital Completed
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: Pan-Chyr Yang, PHD National Taiwan University Hospital

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00155389     History of Changes
Other Study ID Numbers: 940110
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: July 2012

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

Additional relevant MeSH terms:
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Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections