Helicobacter Pylori InfectionPhase 4NCT05874544
Rescue Therapy for Helicobacter Pylori Infection
A Phase 4 study testing Vonoprazan, Bismuth Potassium Citrate and Tetracycline in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 3 sites in China.
Trial summary
Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Vonoprazan, Bismuth Potassium Citrate and Tetracycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 3 sitesChina
- Study dates
- 16 May 2023to 31 Jan 2025
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and willingness to participate in the study and to sign and give informed consent
- Confirmed H. pylori infection and with previous treatment experience
Who cannot join
- subjects naive to H. pylori treatment,
- under 18 or over 80 years old
- history of gastrectomy
- pregnant or lactating women
- Previous history of tuberculosis
- Allergy to any of the study drugs
- severe systemic diseases or malignancy
- administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Second Affiliated Hospital of Zhejiang University school of Medicine
Hangzhou, Zhejiang
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Shanghai Songjiang District Central Hospital
Shanghai, Shanghai Municipality
About this study
Official title: Rifabutin-containing Triple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial
Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Vonoprazan, Bismuth Potassium Citrate, Tetracycline, Metronidazole, Amoxicillin
- Keywords
- Helicobacter pylori, rescue therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Proton pump inhibitor
Bismuth Potassium CitrateDrug
Gastric mucosal protective drug with anti-H. pylori effect
TetracyclineDrug
Antibiotics for H. pylori eradication
MetronidazoleDrug
Antibiotics for H. pylori eradication
AmoxicillinDrug
Antibiotics for H. pylori eradication
RifabutinDrug
Antibiotics for H. pylori eradication
| Study group | Role | What they receive |
|---|---|---|
| Tetracycline Bismuth Quadruple Therapy | Active comparator | Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid Receives: Drug: Vonoprazan; Drug: Bismuth Potassium Citrate; Drug: Tetracycline; Drug: Metronidazole |
| Rifabutin Triple Therapy | Experimental | Vonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid Receives: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Rifabutin |
| Dual Therapy | Experimental | Vonoprazan 20mg bid, amoxicillin 1000mg tid Receives: Drug: Vonoprazan; Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
Measured: Six weeks after completion of therapy
Secondary outcomes (2)
Rate of adverse effects
The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or severe" (causing considerable interference with daily activities). In addition, blood test were messured to access function of liver and kidney.
Measured: Within 7 days after completion of therapy
Compliance rate
Compliance was defined as poor when they had taken less than 80% of the total medication
Measured: Within 7 days after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start16 May 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
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 Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Lu, MD, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874544
- Sponsor's protocol ID
- rjhy20230001
- Status last verified
- Oct 2024
- First submitted
- 16 May 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang Y, Chen JN, Qiu SH, Guo YX, Li MX, Gao YN, Liang X, Han YH, Xu P, Wang J, Lu H. Vonoprazan-amoxicillin dual, rifabutin-based triple, and bismuth quadruple therapies for Helicobacter pylori rescue treatment: a multicentre, open-label, non-inferiority randomised trial. Lancet Reg Health West Pac. 2026 Feb 12;68:101815. doi: 10.1016/j.lanwpc.2026.101815. eCollection 2026 Mar.
PubMed 41732217
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rifabutin-containing Triple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05874544
- Acronym / sponsor ID
- rjhy20230001
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, rescue therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 25 May 2023 (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.
Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tetracycline Bismuth Quadruple Therapy | Active comparator | Drug: Vonoprazan, Drug: Bismuth Potassium Citrate, Drug: Tetracycline, Drug: MetronidazoleVonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid |
| Rifabutin Triple Therapy | Experimental | Drug: Vonoprazan, Drug: Amoxicillin, Drug: RifabutinVonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid |
| Dual Therapy | Experimental | Drug: Vonoprazan, Drug: AmoxicillinVonoprazan 20mg bid, amoxicillin 1000mg tid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability and willingness to participate in the study and to sign and give informed consent
- Confirmed H. pylori infection and with previous treatment experience
Key exclusion criteria (8 listed)
- subjects naive to H. pylori treatment,
- under 18 or over 80 years old
- history of gastrectomy
- pregnant or lactating women
- Previous history of tuberculosis
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 |
|---|---|---|
| VonoprazanProton pump inhibitor | Drug | Dual Therapy, Rifabutin Triple Therapy, Tetracycline Bismuth Quadruple Therapy |
| Bismuth Potassium CitrateGastric mucosal protective drug with anti-H. pylori effect | Drug | Tetracycline Bismuth Quadruple Therapy |
| TetracyclineAntibiotics for H. pylori eradication | Drug | Tetracycline Bismuth Quadruple Therapy |
| MetronidazoleAntibiotics for H. pylori eradication | Drug | Tetracycline Bismuth Quadruple Therapy |
| AmoxicillinAntibiotics for H. pylori eradication | Drug | Dual Therapy, Rifabutin Triple Therapy |
| RifabutinAntibiotics for H. pylori eradication | Drug | Rifabutin Triple Therapy |
Primary outcome
Helicobacter pylori eradication rate
Time frame: Six weeks after completion of therapy
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
2 secondary outcomes
Rate of adverse effects
Time frame: Within 7 days after completion of therapy
Compliance rate
Time frame: Within 7 days after completion of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 41732217Huang Y, Chen JN, Qiu SH, Guo YX, Li MX, Gao YN, Liang X, Han YH, Xu P, Wang J, Lu H. Vonoprazan-amoxicillin dual, rifabutin-based triple, and bismuth quadruple therapies for Helicobacter pylori rescue treatment: a multicentre, open-label, non-inferiority randomised trial. Lancet Reg Health West Pac. 2026 Feb 12;68:101815. doi: 10.1016/j.lanwpc.2026.101815. eCollection 2026 Mar.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 Vonoprazan, Bismuth Potassium Citrate and Tetracycline in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 3 sites 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 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: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication rate (time frame: Six weeks after completion of therapy). 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 NCT05874544, 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 15 Sep 2025.