Helicobacter Pylori InfectionNCT03321773
Comparing the Efficacy of 14-day Reverse Hybrid Therapy and 14-day Triple Therapy Plus Bismuth Therapy
A study testing triple therapy plus bismuth therapy and reverse hybrid therapy in people with Helicobacter Pylori Infection, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
Reverse hybrid therapy achieves a higher eradication rate than bismuth (triple therapy plus bismuth) remains unanswered Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- triple therapy plus bismuth therapy and reverse hybrid therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2017to Dec 2020
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis
Who cannot join
- previous H pylori-eradication therapy
- ingestion of antibiotics or bismuth within the prior 4 weeks
- patients with allergic history to the medications used
- patients with previous gastric surgery
- the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
- pregnant women
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City, 813
Feng-Woei Tsay, Bachelor, 886-7346-2121 ext. 2074, fwchiae@vghks.gov.tw
Ping-I Hsu, MD, 886-7346-8233, pihsu@vghks.gov.tw
About this study
Official title: Compare 14-day Reverse Hybrid Therapy and 14-day Triple Therapy Plus Bismuth on Helicobacter Pylori Eradication
Reverse hybrid therapy achieves a higher eradication rate than bismuth (triple therapy plus bismuth) remains unanswered
Read the detailed description
With the rising prevalence of antimicrobial resistance, the failure rate of the 7-day standard triple therapy has declined to unacceptable level (<80%) worldwide. Several regimens were suggested to replace standard triple therapy in the area with high clarithromycin resistance, including sequential therapy, concomitant therapy, hybrid therapy and bismuth containing quadruple therapy. A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving eradication rates of 95%. A clinical trial by Hsu et al from our hospital showed 12-day reverse hybrid therapy also achieved high eradication rate, and improved the compliance of patients. Even prolong the treatment duration of standard triple therapy from 7 days to 12 days, the efficacy of eradication was still < 90% (85-88%). The limitation of triple therapy in against resistant-stains was still existed. The addition of bismuth (triple therapy plus bismuth) can improve cure rates despite a high prevalence of antimicrobial resistance. The major bismuth effect is to add an additional 30%-40% to the success with resistant infections. However the direct compare the efficacy between 14-day reverse hybrid therapy and 14-day triple therapy plus bismuth is still insufficiency in Taiwan and worldwide. Choosing a navel therapy or a modifying triple therapy can get better efficacy, it is remained to be determined. Besides genotyping polymorphism of CYP2C19 influenced the metabolism of proton pump inhibit, and could cause decreasing of eradication rate of standard triple therapy. But the influence in 14-day reverse hybrid therapy and 14-day triple therapy plus bismuth is unclear.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- triple therapy plus bismuth therapy, reverse hybrid therapy
- Keywords
- Helicobacter pylori, Eradication rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triple therapy plus bismuth therapyDrug
Also called pantoprazole 40 mg, amoxicillin 1g, clarithromycin 500mg, bismuth subcitrate 240mg
pantoprazole 40mg twice daily for 14 days, amoxicillin 1g twice daily for 14 days, clarithromycin 500mg twice daily for 14 days, bismuth subcitrate 240mg twice daily for 14 days.
reverse hybrid therapyDrug
Also called pantoprazole 40mg, amoxicillin 1g, clarithromycin 500mg, metronidazole 500mg
(pantoprazole 40mg twice daily for 7 days, amoxicillin 1 g twice dailyfor 7 days, clarithromycin 500 mg twice daily for 7 days, and metronidazole 500 mg twice daily for 7 days) followed by (pantoprazole 40mg twice daily for 7 days and amoxicillin 1 g twice daily for 7 days)
| Study group | Role | What they receive |
|---|---|---|
| triple therapy plus bismuth therapy | Experimental | pantoprazole 40mg twice daily for 14 days, amoxicillin 1g twice daily for 14 days, clarithromycin 500mg twice daily for 14 days, bismuth subcitrate 240mg twice daily for 14 days. Receives: Drug: triple therapy plus bismuth therapy |
| reverse hybrid therapy | Active comparator | (pantoprazole 40mg twice daily for 7 days, amoxicillin 1 g twice dailyfor 7 days, clarithromycin 500 mg twice daily for 7 days, and metronidazole 500 mg twice daily for 7 days) followed by (pantoprazole 40mg twice daily for 7 days and amoxicillin 1 g twice daily for 7 days) Receives: Drug: reverse hybrid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants in Which H. Pylori Was Eradicated
To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.
Measured: sixth week after the end of anti- H. pylori therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study startJan 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng-Woei Tsay, Kaohsiung Veterans General Hospital.
- Investigators
- Feng-Woei Tsay, Bachelor, Study chair, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321773
- Sponsor's protocol ID
- VGHKS16-CT10-17
- Status last verified
- Mar 2019
- First submitted
- 20 Oct 2017
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare 14-day Reverse Hybrid Therapy and 14-day Triple Therapy Plus Bismuth on Helicobacter Pylori Eradication
- ClinicalTrials.gov ID
- NCT03321773
- Acronym / sponsor ID
- VGHKS16-CT10-17
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Eradication rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Oct 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.
Reverse hybrid therapy achieves a higher eradication rate than bismuth (triple therapy plus bismuth) remains unanswered
Detailed description
With the rising prevalence of antimicrobial resistance, the failure rate of the 7-day standard triple therapy has declined to unacceptable level (<80%) worldwide. Several regimens were suggested to replace standard triple therapy in the area with high clarithromycin resistance, including sequential therapy, concomitant therapy, hybrid therapy and bismuth containing quadruple therapy. A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving eradication rates of 95%. A clinical trial by Hsu et al from our hospital showed 12-day reverse hybrid therapy also achieved high eradication rate, and improved the compliance of patients. Even prolong the treatment duration of standard triple therapy from 7 days to 12 days, the efficacy of eradication was still < 90% (85-88%). The limitation of triple therapy in against resistant-stains was still existed. The addition of bismuth (triple therapy plus bismuth) can improve cure rates despite a high prevalence of antimicrobial resistance. The major bismuth effect is to add an additional 30%-40% to the success with resistant infections. However the direct compare the efficacy between 14-day reverse hybrid therapy and 14-day triple therapy plus bismuth is still insufficiency in Taiwan and worldwide. Choosing a navel therapy or a modifying triple therapy can get better efficacy, it is remained to be determined. Besides genotyping polymorphism of CYP2C19 influenced the metabolism of proton pump inhibit, and could cause decreasing of eradication rate of standard triple therapy. But the influence in 14-day reverse hybrid therapy and 14-day triple therapy plus bismuth is unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| triple therapy plus bismuth therapy | Experimental | Drug: triple therapy plus bismuth therapypantoprazole 40mg twice daily for 14 days, amoxicillin 1g twice daily for 14 days, clarithromycin 500mg twice daily for 14 days, bismuth subcitrate 240mg twice daily for 14 days. |
| reverse hybrid therapy | Active comparator | Drug: reverse hybrid therapy(pantoprazole 40mg twice daily for 7 days, amoxicillin 1 g twice dailyfor 7 days, clarithromycin 500 mg twice daily for 7 days, and metronidazole 500 mg twice daily for 7 days) followed by (pantoprazole 40mg twice daily for 7 days and amoxicillin 1 g twice daily for 7 days) |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis
Key exclusion criteria (6 listed)
- previous H pylori-eradication therapy
- ingestion of antibiotics or bismuth within the prior 4 weeks
- patients with allergic history to the medications used
- patients with previous gastric surgery
- the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
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 |
|---|---|---|
| triple therapy plus bismuth therapyAlso: pantoprazole 40 mg, amoxicillin 1g, clarithromycin 500mg, bismuth subcitrate 240mgpantoprazole 40mg twice daily for 14 days, amoxicillin 1g twice daily for 14 days, clarithromycin 500mg twice daily for 14 days, bismuth subcitrate 240mg twice daily for 14 days. | Drug | triple therapy plus bismuth therapy |
| reverse hybrid therapyAlso: pantoprazole 40mg, amoxicillin 1g, clarithromycin 500mg, metronidazole 500mg(pantoprazole 40mg twice daily for 7 days, amoxicillin 1 g twice dailyfor 7 days, clarithromycin 500 mg twice daily for 7 days, and metronidazole 500 mg twice daily for 7 days) followed by (pantoprazole 40mg twice daily for 7 days and amoxicillin 1 g twice daily for 7 days) | Drug | reverse hybrid therapy |
Primary outcome
Number of Participants in Which H. Pylori Was Eradicated
Time frame: sixth week after the end of anti- H. pylori therapy
To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
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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.
Feng-Woei Tsay, Bachelor study chair
Kaohsiung Veterans General Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triple therapy plus bismuth therapy and reverse hybrid therapy in people with Helicobacter Pylori Infection, run by Kaohsiung Veterans General Hospital. at 1 site 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 6 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 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Feng-Woei Tsay, Bachelor (+886-7-342-2121 ext. 8233, fwchaie@vghks.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants in Which H. Pylori Was Eradicated (time frame: sixth week after the end of anti- H. pylori therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2019.