Helicobacter Pylori InfectionPhase 4NCT07537634
Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication
A Phase 4 study testing vonoprazan-based triple therapy (VAL regimen) and Esomeprazole-based triple therapy (EAL regimen) in people with Helicobacter Pylori Infection and Dyspepsia, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to compare the efficacy and safety of vonoprazan-based levofloxacin-containing triple therapy with esomeprazole-based levofloxacin-containing triple therapy for eradication of Helicobacter pylori infection in adults with dyspepsia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection, Dyspepsia, Peptic Ulcer Disease
- What is being tested?
- vonoprazan-based triple therapy (VAL regimen) and Esomeprazole-based triple therapy (EAL regimen)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBangladesh
- Study dates
- 15 Apr 2026to 14 Sep 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Dyspeptic patients with positive for both rapid urease test and stool antigen test
- Patients giving written informed consent
Who cannot join
- Treatment with a proton pump inhibitor, H2-receptor antagonist within the last 2 weeks, prior to the study
- Treatment with antibiotics or bismuth preparation within 4 weeks prior to the study
- Previous H. pylori eradication therapy
- Gastric or duodenal ulcer with current or recent bleeding on endoscopy
- Significant upper or lower gastrointestinal bleeding within 4 weeks
- Patients with regular intake of NSAIDs or steroids
Show all 15Show fewer
- Surgery that might affect gastric acid secretion e.g., upper GI resection or vagotomy
- Known case of malignancy, including MALToma
- Advanced co-morbidities (e.g., CLD, CKD, cardio-respiratory failure, known thyroid disease)
- Chronic alcohol abuse, chronic illegal drug use, or drug addiction within the past 12 months
- Pregnant, lactating woman or intend to become pregnant within the study period
- History of hypersensitivity to vonoprazan, PPIs, amoxicillin, and/or levofloxacin
- On colchicine
- Subjects with abnormal laboratory test at the start of the screening period:
- creatinine > 2 mg/dl SGPT > 2 x Upper limit of normal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Vonoprazan-Based Triple Therapy and Esomeprazole-Based Triple Therapy for Eradication of Helicobacter Pylori Infection: An Open-Label Randomized Controlled Trial
The goal of this clinical trial is to compare the efficacy and safety of vonoprazan-based levofloxacin-containing triple therapy with esomeprazole-based levofloxacin-containing triple therapy for eradication of Helicobacter pylori infection in adults with dyspepsia.
The main questions it aims to answer are whether vonoprazan-based triple therapy achieves a higher eradication rate of H. pylori, whether it provides greater improvement in dyspeptic symptoms, and what adverse effects are associated with each regimen.
Read more
Researchers will compare the two treatment regimens to determine which is more effective for H. pylori eradication.
Participants with confirmed H. pylori infection will be randomly assigned to receive either vonoprazan-based or esomeprazole-based triple therapy for 14 days.
Four weeks after completion of therapy, participants will undergo repeat stool antigen testing to assess eradication.
Drug compliance, adverse effects, and dyspeptic symptom scores will be recorded during follow-up.
Participants with endoscopic mucosal lesions at baseline will undergo follow-up endoscopy for reassessment.
Read the detailed description
This open-label randomized controlled trial will be conducted in the outpatient Department of Gastroenterology, Bangabandhu Sheikh Mujib Medical University (BMU), following institutional ethical approval. Consecutive adult patients presenting with dyspepsia or symptoms suggestive of peptic ulcer disease will be initially evaluated for enrollment. Eligible patients will undergo screening for Helicobacter pylori infection using a stool antigen test. Fresh stool samples will be collected in sterile containers and analyzed using a one-step chromatographic immunoassay for H. pylori antigen detection.
Patients with positive stool antigen results will undergo upper gastrointestinal endoscopy after assessment of procedural fitness and obtaining written informed consent. Endoscopy will be performed by experienced gastroenterologists using standard endoscopic equipment. During endoscopy, mucosal abnormalities including gastritis, erosions, duodenal ulcers, and gastric ulcers will be documented in a structured data collection form. Biopsy specimens from the gastric antrum and corpus will be obtained for rapid urease testing. Additional biopsies will be taken from suspicious lesions when clinically indicated.
Only patients with positive results on both stool antigen testing and rapid urease testing will be enrolled in the study. Enrolled participants will be randomly assigned in a 1:1 ratio into two treatment groups. One group will receive vonoprazan-based levofloxacin-containing triple therapy, and the other group will receive esomeprazole-based levofloxacin-containing triple therapy. Both treatment regimens will be administered for 14 days. Participants will be instructed regarding medication timing and adherence.
All study medications will be supplied from the same pharmaceutical source and stored under recommended conditions. Participants will be followed at the end of therapy to assess treatment compliance and document any adverse events. A subsequent follow-up visit will be scheduled 4 weeks after completion of therapy, during which repeat stool antigen testing will be performed to assess H. pylori eradication. Participants with mucosal lesions identified at baseline endoscopy will undergo repeat upper gastrointestinal endoscopy to evaluate mucosal healing.
All study findings, including eradication outcomes, treatment adherence, adverse effects, and endoscopic healing status where applicable, will be systematically documented and analyzed upon completion of follow-up.
Statistical analysis:
The following steps will be used to analyze the collected data:
- The entered data will be checked, verified and analyzed by IBM® SPSS® Statistics version 27 (Statistical Program for Social Science) software.
- The data will be presented in tables, figures and diagrammatical form.
- Appropriate statistical test will be applied for data analysis. Numeric data (e.g. age, Likert scale score for dyspepsia) will be expressed as mean ± standard deviation and median (range), qualitative data (e.g. sex, stool antigen test, endoscopy of upper GIT) will be expressed as frequency and percentage.
- Baseline characteristics of the study patients and outcomes will be evaluated using student's t-test, Chi-square test or Fisher's exact test, as appropriate.
- Factors influencing the efficacy of the eradication therapy were assessed by univariate \& multivariate analysis
- A P-value less than 0.05 will be considered as significant at a 95% confidence interval (95% CI).
- Conditions
- Helicobacter Pylori Infection, Dyspepsia, Peptic Ulcer Disease, Helicobacter Pylori, H Pylori
- Being tested
- vonoprazan-based triple therapy (VAL regimen), Esomeprazole-based triple therapy (EAL regimen)
- Keywords
- Helicobacter pylori, Helicobacter pylori eradication, Vonoprazan, Esomeprazole, Levofloxacin, Triple therapy, Dyspepsia
- Medical subject headings
- Dyspepsia, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vonoprazan-based triple therapy (VAL regimen)Drug
vonoprazan 20 mg twice daily (30 minutes before meal), Amoxicillin 1 g twice daily (After meal), Levofloxacin 500 mg once daily for 14 days
Esomeprazole-based triple therapy (EAL regimen)Drug
Esomeprazole 20 mg twice daily (30 minutes before meal), Amoxicillin 1 g twice daily (After meal), Levofloxacin 500 mg once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan-based triple therapy (VAL) | Experimental | Participants in this arms will receive vonoprazan based levofloxacin containing triple therapy for 14 days Receives: Drug: vonoprazan-based triple therapy (VAL regimen) |
| Esomeprazole-based triple therapy (EAL) | Active comparator | Participants in this arms will receive esomeprazole based levofloxacin containing triple therapy for 14 days Receives: Drug: Esomeprazole-based triple therapy (EAL regimen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori Eradication Rate
Proportion of participants with confirmed eradication of Helicobacter pylori, defined as a negative stool antigen test performed 4 weeks after completion of therapy.
Measured: 4 weeks after completion of 14-day therapy
Secondary outcomes (4)
Endoscopic Mucosal Healing rate
Proportion of participants with healed gastric or duodenal mucosal lesions assessed by repeat upper gastrointestinal endoscopy 4 weeks after completion of therapy.
Measured: 4 weeks after completion of therapy.
Change in dyspeptic symptom severity score
Dyspeptic symptoms were assessed using an 8-item, 5-point Likert scale at baseline and 4 weeks after completion of therapy. Each item was scored from 1 (no symptom) to 5 (very severe), yielding a total score ranging from 8 to 40. Lower scores indicated fewer symptoms. Improvement was defined as a reduction in total symptom score from baseline
Measured: 4 weeks after completion of 14-day therapy
Adverse Events
Incidence and type of treatment-related adverse events reported during and up to 4 weeks after completion of therapy.
Measured: During therapy and up to 4 weeks after therapy completion
Compliance to Therapy
Proportion of participants who complete the prescribed 14-day therapy as per protocol.
Measured: End of therapy (14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start15 Apr 2026
- Primary completion14 Sep 2026
- Study completion14 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syeda Mubashsharah Mahfuz, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Syeda Mubashsharah Mahfuz, MBBS, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537634
- Sponsor's protocol ID
- BSMMU/2024/3276
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this article, along with the study protocol and statistical analysis plan, will be made available upon reasonable request to the corresponding author after publication. Data will be shared with researchers who provide a methodologically sound proposal.
Publications
Ahmed, E. U., Alam, R., Alam, F., Ghosh, C. K., Dey, S. K., Masud, H., Ahmed, D. S., Bhuiyan, M. M. R., Mia, Roy, P. K., and Raihan, A. S. M. A. (2009) 'Comparative study between Metronidazole, Amoxycilin, Omeprazole based therapy and Levofloxacin, Amoxycilin, Omeprazole based therapy for helicobacter pylori eradication in peptic ulcer disease', Journal of Chittagong Medical College Teachers Association, 20, pp. 29-32.
Abdelghani, Y. A., Moussa, M. M. (2023) Vonoprazan-Based Versus Esomeprazole-Based Triple Therapy for Helicobacter pylori: A Randomized Trial. Appli Microbiol Open Access. 9:258.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Vonoprazan-Based Triple Therapy and Esomeprazole-Based Triple Therapy for Eradication of Helicobacter Pylori Infection: An Open-Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07537634
- Acronym / sponsor ID
- BSMMU/2024/3276
- Conditions
- Helicobacter Pylori Infection, Dyspepsia, Peptic Ulcer Disease, Helicobacter Pylori, H Pylori
- Keywords
- Helicobacter pylori, Helicobacter pylori eradication, Vonoprazan, Esomeprazole, Levofloxacin, Triple therapy, Dyspepsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 14 Sep 2026 (actual)
- Study completion
- 14 Sep 2026 (actual)
- First posted
- 17 Apr 2026 (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 goal of this clinical trial is to compare the efficacy and safety of vonoprazan-based levofloxacin-containing triple therapy with esomeprazole-based levofloxacin-containing triple therapy for eradication of Helicobacter pylori infection in adults with dyspepsia.
The main questions it aims to answer are whether vonoprazan-based triple therapy achieves a higher eradication rate of H. pylori, whether it provides greater improvement in dyspeptic symptoms, and what adverse effects are associated with each regimen.
Researchers will compare the two treatment regimens to determine which is more effective for H. pylori eradication.
Participants with confirmed H. pylori infection will be randomly assigned to receive either vonoprazan-based or esomeprazole-based triple therapy for 14 days.
Four weeks after completion of therapy, participants will undergo repeat stool antigen testing to assess eradication.
Drug compliance, adverse effects, and dyspeptic symptom scores will be recorded during follow-up.
Participants with endoscopic mucosal lesions at baseline will undergo follow-up endoscopy for reassessment.
Detailed description
This open-label randomized controlled trial will be conducted in the outpatient Department of Gastroenterology, Bangabandhu Sheikh Mujib Medical University (BMU), following institutional ethical approval. Consecutive adult patients presenting with dyspepsia or symptoms suggestive of peptic ulcer disease will be initially evaluated for enrollment. Eligible patients will undergo screening for Helicobacter pylori infection using a stool antigen test. Fresh stool samples will be collected in sterile containers and analyzed using a one-step chromatographic immunoassay for H. pylori antigen detection.
Patients with positive stool antigen results will undergo upper gastrointestinal endoscopy after assessment of procedural fitness and obtaining written informed consent. Endoscopy will be performed by experienced gastroenterologists using standard endoscopic equipment. During endoscopy, mucosal abnormalities including gastritis, erosions, duodenal ulcers, and gastric ulcers will be documented in a structured data collection form. Biopsy specimens from the gastric antrum and corpus will be obtained for rapid urease testing. Additional biopsies will be taken from suspicious lesions when clinically indicated.
Only patients with positive results on both stool antigen testing and rapid urease testing will be enrolled in the study. Enrolled participants will be randomly assigned in a 1:1 ratio into two treatment groups. One group will receive vonoprazan-based levofloxacin-containing triple therapy, and the other group will receive esomeprazole-based levofloxacin-containing triple therapy. Both treatment regimens will be administered for 14 days. Participants will be instructed regarding medication timing and adherence.
All study medications will be supplied from the same pharmaceutical source and stored under recommended conditions. Participants will be followed at the end of therapy to assess treatment compliance and document any adverse events. A subsequent follow-up visit will be scheduled 4 weeks after completion of therapy, during which repeat stool antigen testing will be performed to assess H. pylori eradication. Participants with mucosal lesions identified at baseline endoscopy will undergo repeat upper gastrointestinal endoscopy to evaluate mucosal healing.
All study findings, including eradication outcomes, treatment adherence, adverse effects, and endoscopic healing status where applicable, will be systematically documented and analyzed upon completion of follow-up.
Statistical analysis:
The following steps will be used to analyze the collected data:
- The entered data will be checked, verified and analyzed by IBM® SPSS® Statistics version 27 (Statistical Program for Social Science) software.
- The data will be presented in tables, figures and diagrammatical form.
- Appropriate statistical test will be applied for data analysis. Numeric data (e.g. age, Likert scale score for dyspepsia) will be expressed as mean ± standard deviation and median (range), qualitative data (e.g. sex, stool antigen test, endoscopy of upper GIT) will be expressed as frequency and percentage.
- Baseline characteristics of the study patients and outcomes will be evaluated using student's t-test, Chi-square test or Fisher's exact test, as appropriate.
- Factors influencing the efficacy of the eradication therapy were assessed by univariate \& multivariate analysis
- A P-value less than 0.05 will be considered as significant at a 95% confidence interval (95% CI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan-based triple therapy (VAL) | Experimental | Drug: vonoprazan-based triple therapy (VAL regimen)Participants in this arms will receive vonoprazan based levofloxacin containing triple therapy for 14 days |
| Esomeprazole-based triple therapy (EAL) | Active comparator | Drug: Esomeprazole-based triple therapy (EAL regimen)Participants in this arms will receive esomeprazole based levofloxacin containing triple therapy for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Dyspeptic patients with positive for both rapid urease test and stool antigen test
- Patients giving written informed consent
Key exclusion criteria (15 listed)
- Treatment with a proton pump inhibitor, H2-receptor antagonist within the last 2 weeks, prior to the study
- Treatment with antibiotics or bismuth preparation within 4 weeks prior to the study
- Previous H. pylori eradication therapy
- Gastric or duodenal ulcer with current or recent bleeding on endoscopy
- Significant upper or lower gastrointestinal bleeding within 4 weeks
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 |
|---|---|---|
| vonoprazan-based triple therapy (VAL regimen)vonoprazan 20 mg twice daily (30 minutes before meal), Amoxicillin 1 g twice daily (After meal), Levofloxacin 500 mg once daily for 14 days | Drug | Vonoprazan-based triple therapy (VAL) |
| Esomeprazole-based triple therapy (EAL regimen)Esomeprazole 20 mg twice daily (30 minutes before meal), Amoxicillin 1 g twice daily (After meal), Levofloxacin 500 mg once daily for 14 days | Drug | Esomeprazole-based triple therapy (EAL) |
Primary outcome
H. pylori Eradication Rate
Time frame: 4 weeks after completion of 14-day therapy
Proportion of participants with confirmed eradication of Helicobacter pylori, defined as a negative stool antigen test performed 4 weeks after completion of therapy.
4 secondary outcomes
Endoscopic Mucosal Healing rate
Time frame: 4 weeks after completion of therapy.
Change in dyspeptic symptom severity score
Time frame: 4 weeks after completion of 14-day therapy
Adverse Events
Time frame: During therapy and up to 4 weeks after therapy completion
Compliance to Therapy
Time frame: End of therapy (14 days)
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 26 Oct 2026.
- BackgroundAhmed, E. U., Alam, R., Alam, F., Ghosh, C. K., Dey, S. K., Masud, H., Ahmed, D. S., Bhuiyan, M. M. R., Mia, Roy, P. K., and Raihan, A. S. M. A. (2009) 'Comparative study between Metronidazole, Amoxycilin, Omeprazole based therapy and Levofloxacin, Amoxycilin, Omeprazole based therapy for helicobacter pylori eradication in peptic ulcer disease', Journal of Chittagong Medical College Teachers Association, 20, pp. 29-32.
- BackgroundAbdelghani, Y. A., Moussa, M. M. (2023) Vonoprazan-Based Versus Esomeprazole-Based Triple Therapy for Helicobacter pylori: A Randomized Trial. Appli Microbiol Open Access. 9:258.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this article, along with the study protocol and statistical analysis plan, will be made available upon reasonable request to the corresponding author after publication. Data will be shared with researchers who provide a methodologically sound proposal.
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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.
Syeda Mubashsharah Mahfuz, MBBS principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site 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-based triple therapy (VAL regimen) and Esomeprazole-based triple therapy (EAL regimen) in people with Helicobacter Pylori Infection and Dyspepsia, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 3 inclusion and 15 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 26 Oct 2026. 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 Bangladesh. 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?
H. pylori Eradication Rate (time frame: 4 weeks after completion of 14-day 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 NCT07537634, which also lists 2 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 26 Oct 2026.