Helicobacter Pylori InfectionNCT05189444
The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori
A study testing Vonoprazan, Amoxicillin and Esomeprazole in people with Helicobacter Pylori Infection, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The eradication rate of standard quadruple therapy has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Vonoprazan, Amoxicillin and Esomeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 672 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2022to 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Helicobacter pylori infected patients comfirmed by 13C/14C UBT
- age 18~65
Who cannot join
- prior Hp eradication therapy including amoxicillin and clarithromycin
- previous gastric resection
- allergic to the drugs used in this study
- previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics, probiotics within 4 weeks of the study
- Patients who were pregnant or lactating
- Patients taking NSAIDs, alcoholic or with other serious disease (e.g. hepatopathy, heart disease, nephropathy#diabete mellitus, hypertension…) effect the evaluation of this study
- Can't express the complaint correctly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori: a Prospective, Multi-Center, Randomized Controlled Trial
The eradication rate of standard quadruple therapy has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. The aim of this prospective study is to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin, and Bismuth for eradication of Hp, compared with standard quadruple therapy.
Read the detailed description
In China, the first-line therapy to treat Helicobacter pylori (Hp) consists of a bismuth-based proton pump inhibitor (PPI) and two antibiotics for 14 days.But, eradication has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. Vonoprazan is a novel potassium-competitive acid blocker more effective in suppressing acid production than proton pump inhibitors (PPIs). Several studies previously suggested that vonoprazan containing antibiotic therapy was superior to other PPI-containing therapies for Hp. Most strains of Helicobacter pylori are sensitive to amoxicillin. Bismuth salts, a topical agent, which are available in our country, have a synergistic effect on antibiotics and decrease the bacterial load. Therefore, the investigators performed a prospective, multi-center, randomized trial, to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin, and Bismuth for eradication of Hp, compared with standard quadruple therapy.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Vonoprazan, Amoxicillin, Esomeprazole, Clarithromycin, Bismuth potassium citrate
- Keywords
- Vonoprazan, Standard Quadruple Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
20mg bid
AmoxicillinDrug
0.75g tid
EsomeprazoleDrug
20mg bid
AmoxicillinDrug
1.0g bid
ClarithromycinDrug
0.5g bid
Bismuth potassium citrateDrug
0.22g bid
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan group | Experimental | Vonoprazan + Amoxicillin + Bismuth potassium citrate Drug: Vonoprazan 20mg bid Other Names: no Drug: Amoxicillin 0.75g tid Other Names: no Drug: Bismuth potassium citrate 0.22g bid Other Names: no Receives: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Bismuth potassium citrate |
| control group: quadruple therapy | Active comparator | Drug: Esomeprazole 20mg bid Other Names: no Drug: Amoxicillin 1.0g bid Other Names: no Drug: Clarithromycin 0.5g bid Other Names:no Drug: Bismuth potassium citrate 0.22g bid Other Names:no Receives: Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Bismuth potassium citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication
to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin and Bismuth for eradication of Hp, compared with standard quadruple therapy.
Measured: 6 weeks after treatment initiation
Secondary outcomes (1)
Incidence of adverse events
to investigate the incidence of adverse events of Triple Therapy with Vonoprazan, Amoxicillin and Bismuth, compared with standard quadruple therapy.
Measured: 2 weeks and 6 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start25 Mar 2022 (estimated)
- Primary completion31 Dec 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.
- Publications (5)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 Huazhong University of Science and TechnologyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 672 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Cheng, Huazhong University of Science and Technology
- Investigators
- Bin Cheng, Doctor, Principal investigator, Tongji Hospitalsi xiong, Doctor, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189444
- Sponsor's protocol ID
- Vonoprazan-Hp-2021
- Status last verified
- Mar 2022
- First submitted
- 29 Dec 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gunaratne AW, Hamblin H, Clancy A, Magat AJMC, Dawson MVM, Tu J, Borody TJ. Combinations of antibiotics and vonoprazan for the treatment of Helicobacter pylori infections-Exploratory study. Helicobacter. 2021 Oct;26(5):e12830. doi: 10.1111/hel.12830. Epub 2021 Jul 10.
PubMed 34247436Rokkas T, Gisbert JP, Malfertheiner P, Niv Y, Gasbarrini A, Leja M, Megraud F, O'Morain C, Graham DY. Comparative Effectiveness of Multiple Different First-Line Treatment Regimens for Helicobacter pylori Infection: A Network Meta-analysis. Gastroenterology. 2021 Aug;161(2):495-507.e4. doi: 10.1053/j.gastro.2021.04.012. Epub 2021 Apr 8.
PubMed 33839101Kiyotoki S, Nishikawa J, Sakaida I. Efficacy of Vonoprazan for Helicobacter pylori Eradication. Intern Med. 2020 Jan 15;59(2):153-161. doi: 10.2169/internalmedicine.2521-18. Epub 2019 Jun 27.
PubMed 31243237Ang TL, Ang D. Helicobacter pylori Treatment Strategies in Singapore. Gut Liver. 2021 Jan 15;15(1):13-18. doi: 10.5009/gnl19308.
PubMed 31875670Kao CY, Sheu BS, Wu JJ. Helicobacter pylori infection: An overview of bacterial virulence factors and pathogenesis. Biomed J. 2016 Feb;39(1):14-23. doi: 10.1016/j.bj.2015.06.002. Epub 2016 Apr 1.
PubMed 27105595
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori: a Prospective, Multi-Center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05189444
- Acronym / sponsor ID
- Vonoprazan-Hp-2021
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Vonoprazan, Standard Quadruple Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 672 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 25 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Jan 2022 (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 eradication rate of standard quadruple therapy has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. The aim of this prospective study is to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin, and Bismuth for eradication of Hp, compared with standard quadruple therapy.
Detailed description
In China, the first-line therapy to treat Helicobacter pylori (Hp) consists of a bismuth-based proton pump inhibitor (PPI) and two antibiotics for 14 days.But, eradication has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. Vonoprazan is a novel potassium-competitive acid blocker more effective in suppressing acid production than proton pump inhibitors (PPIs). Several studies previously suggested that vonoprazan containing antibiotic therapy was superior to other PPI-containing therapies for Hp. Most strains of Helicobacter pylori are sensitive to amoxicillin. Bismuth salts, a topical agent, which are available in our country, have a synergistic effect on antibiotics and decrease the bacterial load. Therefore, the investigators performed a prospective, multi-center, randomized trial, to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin, and Bismuth for eradication of Hp, compared with standard quadruple therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan group | Experimental | Drug: Vonoprazan, Drug: Amoxicillin, Drug: Bismuth potassium citrateVonoprazan + Amoxicillin + Bismuth potassium citrate Drug: Vonoprazan 20mg bid Other Names: no Drug: Amoxicillin 0.75g tid Other Names: no Drug: Bismuth potassium citrate 0.22g bid Other Names: no |
| control group: quadruple therapy | Active comparator | Drug: Esomeprazole, Drug: Amoxicillin, Drug: Clarithromycin, Drug: Bismuth potassium citrateDrug: Esomeprazole 20mg bid Other Names: no Drug: Amoxicillin 1.0g bid Other Names: no Drug: Clarithromycin 0.5g bid Other Names:no Drug: Bismuth potassium citrate 0.22g bid Other Names:no |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Helicobacter pylori infected patients comfirmed by 13C/14C UBT
- age 18~65
Key exclusion criteria (7 listed)
- prior Hp eradication therapy including amoxicillin and clarithromycin
- previous gastric resection
- allergic to the drugs used in this study
- previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics, probiotics within 4 weeks of the study
- Patients who were pregnant or lactating
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 |
|---|---|---|
| Vonoprazan20mg bid | Drug | Vonoprazan group |
| Amoxicillin0.75g tid | Drug | Vonoprazan group |
| Esomeprazole20mg bid | Drug | control group: quadruple therapy |
| Amoxicillin1.0g bid | Drug | control group: quadruple therapy |
| Clarithromycin0.5g bid | Drug | control group: quadruple therapy |
| Bismuth potassium citrate0.22g bid | Drug | Vonoprazan group, control group: quadruple therapy |
Primary outcome
Helicobacter pylori eradication
Time frame: 6 weeks after treatment initiation
to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin and Bismuth for eradication of Hp, compared with standard quadruple therapy.
1 secondary outcome
Incidence of adverse events
Time frame: 2 weeks and 6 weeks after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Results publication: PubMed 34247436Gunaratne AW, Hamblin H, Clancy A, Magat AJMC, Dawson MVM, Tu J, Borody TJ. Combinations of antibiotics and vonoprazan for the treatment of Helicobacter pylori infections-Exploratory study. Helicobacter. 2021 Oct;26(5):e12830. doi: 10.1111/hel.12830. Epub 2021 Jul 10.
- Results publication: PubMed 33839101Rokkas T, Gisbert JP, Malfertheiner P, Niv Y, Gasbarrini A, Leja M, Megraud F, O'Morain C, Graham DY. Comparative Effectiveness of Multiple Different First-Line Treatment Regimens for Helicobacter pylori Infection: A Network Meta-analysis. Gastroenterology. 2021 Aug;161(2):495-507.e4. doi: 10.1053/j.gastro.2021.04.012. Epub 2021 Apr 8.
- Results publication: PubMed 31243237Kiyotoki S, Nishikawa J, Sakaida I. Efficacy of Vonoprazan for Helicobacter pylori Eradication. Intern Med. 2020 Jan 15;59(2):153-161. doi: 10.2169/internalmedicine.2521-18. Epub 2019 Jun 27.
- Results publication: PubMed 31875670Ang TL, Ang D. Helicobacter pylori Treatment Strategies in Singapore. Gut Liver. 2021 Jan 15;15(1):13-18. doi: 10.5009/gnl19308.
- Results publication: PubMed 27105595Kao CY, Sheu BS, Wu JJ. Helicobacter pylori infection: An overview of bacterial virulence factors and pathogenesis. Biomed J. 2016 Feb;39(1):14-23. doi: 10.1016/j.bj.2015.06.002. Epub 2016 Apr 1.
- 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.
Bin Cheng, Doctor principal investigator
Tongji Hospital
si xiong, Doctor study chair
Tongji 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 Vonoprazan, Amoxicillin and Esomeprazole in people with Helicobacter Pylori Infection, run by Huazhong University of Science and Technology at 1 site in China.
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 2 inclusion and 7 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 22 Mar 2022. 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 China. 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 Bin Cheng, Doctor (027-83663334, bcheng@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication (time frame: 6 weeks after treatment initiation). 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 NCT05189444, which also lists 5 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 22 Mar 2022.