HelicobacterPhase 4NCT03156855
Sequential Therapy Versus Quadruple Therapy in H. Pylori Eradication
A Phase 4 study testing 14-day sequential therapy and Bismuth quadruple therapy in people with Helicobacter, run by National Taiwan University Hospital at 7 sites in Taiwan.
Trial summary
The investigators aimed to 1. compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the first line and second line treatment 2. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter
- What is being tested?
- 14-day sequential therapy and Bismuth quadruple therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 7 sitesTaiwan
- Study dates
- Sep 2015to Dec 2019
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. H. pylori infected patients naïve to eradication therapies will be eligible in this study.
Who cannot join
- children and teenagers aged less than 20 years,
- history of gastrectomy,
- gastric malignancy, including adenocarcinoma and lymphoma,
- previous allergic reaction to antibiotics (bismuth, amoxicillin, metronidazole, clarithromycin, tetracycline) and PPI (esomeprazole),
- contraindication to treatment drugs,
- pregnant or lactating women,
- severe concurrent disease,
- concomitant use of clopidogrel, or (9) Unwilling to accept random assignment of subjects
Trial locations and contacts
7 sites in 1 country.
Jyh-Ming Liou, MD, PhD contact
7 sites in 1 country
Taiwan7 sites, 7 recruiting
- Recruiting
Chiayi Christian Hospital
Chiayi City
Po-Yuei Chen
- Recruiting
National Taiwan University Hospital, Hsinchu Branch
Hsinchu
Wen-Feng Hsu
- Recruiting
E-DA University Hospital
Kaohsiung City
Chi-Yang Chang, MD
- Recruiting
Jyh-Ming Liou
Taipei
Jyh-Ming Liou, MD, PhD, 886972651883, jyhmingliou@gmail.com
- Recruiting
Taipei Veteran General Hospital
Taipei
Jing-Chuang Luo
- Recruiting
Mackay Memorial Hospital, Taitung branch
Taitung
Ming-Chung Bair
- Recruiting
National Taiwan University Hospital, Yun-Lin Branch
Yunlin County
Yu-Ren Fang, MD, 886972655474
About this study
Official title: Comparison of the Efficacy of Sequential Therapy and Bismuth Quadruple Therapy in the First Line and Second Line Therapy for Helicobacter Pylori Infection- A Multi-center Randomized Trial
The investigators aimed to
- compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the first line and second line treatment
- assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens
- assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora
- assess the impact of eradication therapy on the metabolic factors
Read the detailed description
Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection reduces the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. Sequential therapy for 10 days has been shown to be more effective than triple therapy for 7 and 10 days. The investigators further demonstrated that sequential therapy given for 14 days was superior to triple therapy given for 14 days. Recently, the investigators also found that bismuth quadruple therapy given for 10 days appeared to be more effective than triple therapy given for 14 days in the first line therapy. However, whether sequential therapy given for 14 days is more effective than bismuth quadruple therapy or triple therapy for 14 days remains unknown.
- Conditions
- Helicobacter
- Being tested
- 14-day sequential therapy, Bismuth quadruple therapy
- Keywords
- efficacy, safety, H. pylori eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14-day sequential therapyDrug
Also called S14
D1-D7: (esomeprazole 40mg qid + amoxicillin 500mg qid) for 7 days D8-D14: (esomeprazole 40mg qid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days
Bismuth quadruple therapyDrug
Also called Q10
D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days
| Study group | Role | What they receive |
|---|---|---|
| sequential therapy for 14 days (S14) | Experimental | 14 day sequential therapy Receives: Drug: 14-day sequential therapy |
| bismuth quadruple therapy (Q10) | Active comparator | Bismuth quadruple therapy Receives: Drug: Bismuth quadruple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate: determined by urea breath test (13C-UBT, according to ITT analysis)
No eradicated divided by total cases by intention to treat analysis. 13C-UBT will be used to determine the H. pylori status at least 6 weeks after completion of treatment. A delta value of > 4 units will be defined as positive for H. pylori infection as our previous studies.
Measured: 6 weeks
Secondary outcomes (2)
adverse effect: occurrence of any adverse effect during the treatment
adverse effects related to treatment by per protocol analysis. The patients will be informed of the common side effects from the studied drugs prior to therapy. They will also be asked to record these symptoms during treatment. A standardized interview at the outpatient clinic at the end of treatment will be arranged. The adverse events and compliance will be assessed by the research staffs with pre-defined case report form.
Measured: 2 weeks
changes of antibiotic resistance
changes of antibiotic resistance of E. coli by per protocol analysis
Measured: 2 weeks, 8 weeks, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study startSep 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HelicobacterStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- E-DA Hospital, National Taiwan University Hospital Hsin-Chu Branch, Taipei Veterans General Hospital, Taiwan, Kaohsiung Medical University, Chiayi Christian Hospital, Mackay Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Ming-Shiang Wu, MD, PhD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156855
- Sponsor's protocol ID
- 201506129MINC
- Status last verified
- May 2017
- First submitted
- 30 Sep 2015
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Liou JM, Chen CC, Fang YJ, Chen PY, Chang CY, Chou CK, Chen MJ, Tseng CH, Lee JY, Yang TH, Chiu MC, Yu JJ, Kuo CC, Luo JC, Hsu WF, Hu WH, Tsai MH, Lin JT, Shun CT, Twu G, Lee YC, Bair MJ, Wu MS; Members of the Taiwan Gastrointestinal Disease and Helicobacter Consortium. 14 day sequential therapy versus 10 day bismuth quadruple therapy containing high-dose esomeprazole in the first-line and second-line treatment of Helicobacter pylori: a multicentre, non-inferiority, randomized trial. J Antimicrob Chemother. 2018 Sep 1;73(9):2510-2518. doi: 10.1093/jac/dky183.
PubMed 29846605
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Sequential Therapy and Bismuth Quadruple Therapy in the First Line and Second Line Therapy for Helicobacter Pylori Infection- A Multi-center Randomized Trial
- ClinicalTrials.gov ID
- NCT03156855
- Acronym / sponsor ID
- 201506129MINC
- Conditions
- Helicobacter
- Keywords
- efficacy, safety, H. pylori eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- E-DA Hospital, National Taiwan University Hospital Hsin-Chu Branch, Taipei Veterans General Hospital, Taiwan, Kaohsiung Medical University, Chiayi Christian Hospital, Mackay Memorial Hospital
- Study start
- Sep 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 17 May 2017 (actual)
- 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.
The investigators aimed to
- compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the first line and second line treatment
- assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens
- assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora
- assess the impact of eradication therapy on the metabolic factors
Detailed description
Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection reduces the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. Sequential therapy for 10 days has been shown to be more effective than triple therapy for 7 and 10 days. The investigators further demonstrated that sequential therapy given for 14 days was superior to triple therapy given for 14 days. Recently, the investigators also found that bismuth quadruple therapy given for 10 days appeared to be more effective than triple therapy given for 14 days in the first line therapy. However, whether sequential therapy given for 14 days is more effective than bismuth quadruple therapy or triple therapy for 14 days remains unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sequential therapy for 14 days (S14) | Experimental | Drug: 14-day sequential therapy14 day sequential therapy |
| bismuth quadruple therapy (Q10) | Active comparator | Drug: Bismuth quadruple therapyBismuth quadruple therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. H. pylori infected patients naïve to eradication therapies will be eligible in this study.
Key exclusion criteria (8 listed)
- children and teenagers aged less than 20 years,
- history of gastrectomy,
- gastric malignancy, including adenocarcinoma and lymphoma,
- previous allergic reaction to antibiotics (bismuth, amoxicillin, metronidazole, clarithromycin, tetracycline) and PPI (esomeprazole),
- contraindication to treatment drugs,
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 |
|---|---|---|
| 14-day sequential therapyAlso: S14D1-D7: (esomeprazole 40mg qid + amoxicillin 500mg qid) for 7 days D8-D14: (esomeprazole 40mg qid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days | Drug | sequential therapy for 14 days (S14) |
| Bismuth quadruple therapyAlso: Q10D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days | Drug | bismuth quadruple therapy (Q10) |
Primary outcome
Eradication rate: determined by urea breath test (13C-UBT, according to ITT analysis)
Time frame: 6 weeks
No eradicated divided by total cases by intention to treat analysis. 13C-UBT will be used to determine the H. pylori status at least 6 weeks after completion of treatment. A delta value of > 4 units will be defined as positive for H. pylori infection as our previous studies.
2 secondary outcomes
adverse effect: occurrence of any adverse effect during the treatment
Time frame: 2 weeks
changes of antibiotic resistance
Time frame: 2 weeks, 8 weeks, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Derived from this study: PubMed 29846605Liou JM, Chen CC, Fang YJ, Chen PY, Chang CY, Chou CK, Chen MJ, Tseng CH, Lee JY, Yang TH, Chiu MC, Yu JJ, Kuo CC, Luo JC, Hsu WF, Hu WH, Tsai MH, Lin JT, Shun CT, Twu G, Lee YC, Bair MJ, Wu MS; Members of the Taiwan Gastrointestinal Disease and Helicobacter Consortium. 14 day sequential therapy versus 10 day bismuth quadruple therapy containing high-dose esomeprazole in the first-line and second-line treatment of Helicobacter pylori: a multicentre, non-inferiority, randomized trial. J Antimicrob Chemother. 2018 Sep 1;73(9):2510-2518. doi: 10.1093/jac/dky183.
- Individual participant dataSharing planned: No
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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.
Jyh-Ming Liou, MD, PhD contact
Ming-Shiang Wu, MD, PhD study director
National Taiwan University Hospital
7 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 14-day sequential therapy and Bismuth quadruple therapy in people with Helicobacter, run by National Taiwan University Hospital at 7 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 8 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 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 Jyh-Ming Liou, MD, PhD (dtmed046@pchome.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate: determined by urea breath test (13C-UBT, according to ITT analysis) (time frame: 6 weeks). 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 NCT03156855, which also lists 1 linked publication.
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 17 May 2017.