Helicobacter Pylori InfectionPhase 4NCT00155389
Community-based Helicobacter Pylori Eradication
A Phase 4 study testing Helicobacter pylori eradication in people with Helicobacter Pylori Infection, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Helicobacter pylori eradication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2004to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Helicobacter pylori infection subjects
Who cannot join
- Prior gastrectomy; pregnant women
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 1 recruiting
- Recruiting
Lee Yi-Chia
Taipei, 10015
Yi-Chia Lee, MD, MSc, 23123456 ext. 63351, yichialee@ntu.edu.tw
Jaw-Town Lin, MD, PhD
- Completed
National Taiwan University Hospital
Taipei, 100
About this 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
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.
Read the 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:
- Determine the efficacy of a novel regimen to treat the H. pylori infection in the general population.
- To address the question whether the premalignant gastric lesion could be reversed following the cure of infection.
- To simulate the cost-effectiveness of this chemoprevention.
- To use individual data to empirically calculate the cost-effectiveness of this intervention.
- To address the host genetic susceptibility to gastric cancer development.
- To follow-up the gastric cancer incidence following the eradication of H. pylori.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Helicobacter pylori eradication
- Keywords
- Helicobacter pylori, Gastric cancer, single nucleotide polymorphism
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helicobacter pylori eradicationDrug
Also called Chemoprevention
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.
| Study group | Role | What they receive |
|---|---|---|
| H pylori eradication | Active comparator | All enrolled subjects received chemoprevention with Helicobacter pylori eradication Receives: Drug: Helicobacter pylori eradication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful helicobacter eradication, change in premalignant gastric lesion, and change in gastric cancer incidence rate
Measured: 12 years
Secondary outcomes (1)
Intragastric histologic change
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pan-Chyr Yang, PHD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155389
- Sponsor's protocol ID
- 940110
- Status last verified
- Jul 2012
- First submitted
- 8 Sep 2005
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee YC, Lin JT, Wu HM, Liu TY, Yen MF, Chiu HM, Wang HP, Wu MS, Hsiu-Hsi Chen T. Cost-effectiveness analysis between primary and secondary preventive strategies for gastric cancer. Cancer Epidemiol Biomarkers Prev. 2007 May;16(5):875-85. doi: 10.1158/1055-9965.EPI-06-0758.
PubMed 17507609Liu CY, Wu CY, Lin JT, Lee YC, Yen AM, Chen TH. Multistate and multifactorial progression of gastric cancer: results from community-based mass screening for gastric cancer. J Med Screen. 2006;13 Suppl 1:S2-5.
PubMed 17227633Lee YC, Lin JT, Chen TH, Wu MS. Is eradication of Helicobacter pylori the feasible way to prevent gastric cancer? New evidence and progress, but still a long way to go. J Formos Med Assoc. 2008 Aug;107(8):591-9. doi: 10.1016/S0929-6646(08)60176-X.
PubMed 18678542Lee YC, Wu HM, Chen TH, Liu TY, Chiu HM, Chang CC, Wang HP, Wu MS, Chiang H, Wu MC, Lin JT. A community-based study of Helicobacter pylori therapy using the strategy of test, treat, retest, and re-treat initial treatment failures. Helicobacter. 2006 Oct;11(5):418-24. doi: 10.1111/j.1523-5378.2006.00432.x.
PubMed 16961802Chiang TH, Chang WJ, Chen SL, Yen AM, Fann JC, Chiu SY, Chen YR, Chuang SL, Shieh CF, Liu CY, Chiu HM, Chiang H, Shun CT, Lin MW, Wu MS, Lin JT, Chan CC, Graham DY, Chen HH, Lee YC. Mass eradication of Helicobacter pylori to reduce gastric cancer incidence and mortality: a long-term cohort study on Matsu Islands. Gut. 2021 Feb;70(2):243-250. doi: 10.1136/gutjnl-2020-322200. Epub 2020 Aug 13.
PubMed 32792335Lee YC, Chen TH, Chiu HM, Shun CT, Chiang H, Liu TY, Wu MS, Lin JT. The benefit of mass eradication of Helicobacter pylori infection: a community-based study of gastric cancer prevention. Gut. 2013 May;62(5):676-82. doi: 10.1136/gutjnl-2012-302240. Epub 2012 Jun 14.
PubMed 22698649
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00155389
- Acronym / sponsor ID
- 940110
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Gastric cancer, single nucleotide polymorphism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Determine the efficacy of a novel regimen to treat the H. pylori infection in the general population.
- To address the question whether the premalignant gastric lesion could be reversed following the cure of infection.
- To simulate the cost-effectiveness of this chemoprevention.
- To use individual data to empirically calculate the cost-effectiveness of this intervention.
- To address the host genetic susceptibility to gastric cancer development.
- To follow-up the gastric cancer incidence following the eradication of H. pylori.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H pylori eradication | Active comparator | Drug: Helicobacter pylori eradicationAll enrolled subjects received chemoprevention with Helicobacter pylori eradication |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Helicobacter pylori infection subjects
Key exclusion criteria (1 listed)
- Prior gastrectomy; pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helicobacter pylori eradicationAlso: ChemopreventionFor 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. | Drug | H pylori eradication |
Primary outcome
Successful helicobacter eradication, change in premalignant gastric lesion, and change in gastric cancer incidence rate
Time frame: 12 years
1 secondary outcome
Intragastric histologic change
Time frame: 12 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
- Background: PubMed 17507609Lee YC, Lin JT, Wu HM, Liu TY, Yen MF, Chiu HM, Wang HP, Wu MS, Hsiu-Hsi Chen T. Cost-effectiveness analysis between primary and secondary preventive strategies for gastric cancer. Cancer Epidemiol Biomarkers Prev. 2007 May;16(5):875-85. doi: 10.1158/1055-9965.EPI-06-0758.
- Background: PubMed 17227633Liu CY, Wu CY, Lin JT, Lee YC, Yen AM, Chen TH. Multistate and multifactorial progression of gastric cancer: results from community-based mass screening for gastric cancer. J Med Screen. 2006;13 Suppl 1:S2-5.
- Background: PubMed 18678542Lee YC, Lin JT, Chen TH, Wu MS. Is eradication of Helicobacter pylori the feasible way to prevent gastric cancer? New evidence and progress, but still a long way to go. J Formos Med Assoc. 2008 Aug;107(8):591-9. doi: 10.1016/S0929-6646(08)60176-X.
- Results publication: PubMed 16961802Lee YC, Wu HM, Chen TH, Liu TY, Chiu HM, Chang CC, Wang HP, Wu MS, Chiang H, Wu MC, Lin JT. A community-based study of Helicobacter pylori therapy using the strategy of test, treat, retest, and re-treat initial treatment failures. Helicobacter. 2006 Oct;11(5):418-24. doi: 10.1111/j.1523-5378.2006.00432.x.
- Derived from this study: PubMed 32792335Chiang TH, Chang WJ, Chen SL, Yen AM, Fann JC, Chiu SY, Chen YR, Chuang SL, Shieh CF, Liu CY, Chiu HM, Chiang H, Shun CT, Lin MW, Wu MS, Lin JT, Chan CC, Graham DY, Chen HH, Lee YC. Mass eradication of Helicobacter pylori to reduce gastric cancer incidence and mortality: a long-term cohort study on Matsu Islands. Gut. 2021 Feb;70(2):243-250. doi: 10.1136/gutjnl-2020-322200. Epub 2020 Aug 13.
- Derived from this study: PubMed 22698649Lee YC, Chen TH, Chiu HM, Shun CT, Chiang H, Liu TY, Wu MS, Lin JT. The benefit of mass eradication of Helicobacter pylori infection: a community-based study of gastric cancer prevention. Gut. 2013 May;62(5):676-82. doi: 10.1136/gutjnl-2012-302240. Epub 2012 Jun 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pan-Chyr Yang, PHD study chair
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Helicobacter pylori eradication in people with Helicobacter Pylori Infection, run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pan-Chyr Yang, PHD (886-2-2356-2000, pcyang@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful helicobacter eradication, change in premalignant gastric lesion, and change in gastric cancer incidence rate (time frame: 12 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00155389, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012.