NCT07537634 Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication
| NCT ID | NCT07537634 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
| Condition | Helicobacter Pylori Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2026-08-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2026-04-15 with a primary completion date of 2026-08-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Dyspeptic patients with positive for both rapid urease test and stool antigen test 3. Patients giving written informed consent Exclusion Criteria: 1. Treatment with a proton pump inhibitor, H2-receptor antagonist within the last 2 weeks, prior to the study 2. Treatment with antibiotics or bismuth preparation within 4 weeks prior to the study 3. Previous H. pylori eradication therapy 4. Gastric or duodenal ulcer with current or recent bleeding on endoscopy 5. Significant upper or lower gastrointestinal bleeding within 4 weeks 6. Patients with regular intake of NSAIDs or steroids 7. Surgery that might affect gastric acid secretion e.g., upper GI resection or vagotomy 8. Known case of malignancy, including MALToma 9. Advanced co-morbidities (e.g., CLD, CKD, cardio-respiratory failure, known thyroid disease) 10. Chronic alcohol abuse, chronic illegal drug use, or drug addiction within the past 12 months 11. Pregnant, lactating woman or intend to become pregnant within the study period 12. History of hypersensitivity to vonoprazan, PPIs, amoxicillin, and/or levofloxacin 13. On colchicine 14. Subjects with abnormal laboratory test at the start of the screening period: S. creatinine \> 2 mg/dl SGPT \> 2 x Upper limit of normal
Contact & Investigator
Syeda Mubashsharah Mahfuz, MBBS
PRINCIPAL INVESTIGATOR
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Frequently Asked Questions
Who can join the NCT07537634 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Helicobacter Pylori Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07537634 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07537634 currently recruiting?
Yes, NCT07537634 is actively recruiting participants. Contact the research team at mubashsharah68dmc@gmail.com for enrollment information.
Where is the NCT07537634 trial being conducted?
This trial is being conducted at Dhaka, Bangladesh, Dhaka, Bangladesh.
Who is sponsoring the NCT07537634 clinical trial?
NCT07537634 is sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. The principal investigator is Syeda Mubashsharah Mahfuz, MBBS at Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. The trial plans to enroll 80 participants.