Helicobacter Pylori InfectionNCT04566211
Comparing the Efficacy of 10-day Reverse Hybrid Therapy and 10-day Triple Therapy Plus Bismuth Therapy.
A study testing (panto+amox+clar+metr)+(panto+amox) and pantoprazole+bismuth+amox+clar 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 triple therapy plus bismuth therapy 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?
- (panto+amox+clar+metr)+(panto+amox) and pantoprazole+bismuth+amox+clar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 31 Dec 2022
- 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, 886-7346-8233, fwchaie@vghks.gov.tw
About this study
Official title: Comparing 10-day Reverse Hybrid Therapy and 10-day Triple Therapy Plus Bismuth Therapy on Helicobacter Pylori Eradication
Reverse hybrid therapy achieves a higher eradication rate than triple therapy plus bismuth therapy 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 10-day reverse hybrid therapy and 10-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 10-day reverse hybrid therapy and 10-day triple therapy plus bismuth is unclear.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- (panto+amox+clar+metr)+(panto+amox), pantoprazole+bismuth+amox+clar
- Keywords
- Helicobacter pylori, Eradication rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(panto+amox+clar+metr)+(panto+amox)Drug
Also called pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg, metronidazole 500 mg
a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 3-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
pantoprazole+bismuth+amox+clarDrug
Also called pantoprazole 40 mg, bismuth subcitrate 120 mg, amoxicillin 1 g, clarithromycin 500 mg
pantoprazole 40 mg twice daily, bismuth subcitrate 240 mg twice daily, and amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| (panto+amox+clar+metr)+(panto+amox) | Experimental | a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 3-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily Receives: Drug: (panto+amox+clar+metr)+(panto+amox) |
| pantoprazole+bismuth+amox+clar | Active comparator | pantoprazole 40 mg twice daily, bismuth subcitrate 240 mg twice daily, and amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily for 10 days Receives: Drug: pantoprazole+bismuth+amox+clar |
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 posted28 Sep 2020
- Study start1 Jan 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (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
- Single blind
- Who is masked
- Investigator
- 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, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566211
- Sponsor's protocol ID
- VGHKS19-CT6-15
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 28 Sep 2020
- 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 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing 10-day Reverse Hybrid Therapy and 10-day Triple Therapy Plus Bismuth Therapy on Helicobacter Pylori Eradication
- ClinicalTrials.gov ID
- NCT04566211
- Acronym / sponsor ID
- VGHKS19-CT6-15
- 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
- 1 Jan 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Sep 2020 (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 triple therapy plus bismuth therapy 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 10-day reverse hybrid therapy and 10-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 10-day reverse hybrid therapy and 10-day triple therapy plus bismuth is unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (panto+amox+clar+metr)+(panto+amox) | Experimental | Drug: (panto+amox+clar+metr)+(panto+amox)a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 3-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily |
| pantoprazole+bismuth+amox+clar | Active comparator | Drug: pantoprazole+bismuth+amox+clarpantoprazole 40 mg twice daily, bismuth subcitrate 240 mg twice daily, and amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily for 10 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 |
|---|---|---|
| (panto+amox+clar+metr)+(panto+amox)Also: pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg, metronidazole 500 mga 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 3-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily | Drug | (panto+amox+clar+metr)+(panto+amox) |
| pantoprazole+bismuth+amox+clarAlso: pantoprazole 40 mg, bismuth subcitrate 120 mg, amoxicillin 1 g, clarithromycin 500 mgpantoprazole 40 mg twice daily, bismuth subcitrate 240 mg twice daily, and amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily for 10 days | Drug | pantoprazole+bismuth+amox+clar |
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 28 Sep 2020.
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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 principal investigator
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 (panto+amox+clar+metr)+(panto+amox) and pantoprazole+bismuth+amox+clar 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 28 Sep 2020. 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. 72075, 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 28 Sep 2020.