A Phase 4 interventional study of vonoprazan-based triple therapy (VAL regimen) and Esomeprazole-based triple therapy (EAL regimen) in Helicobacter Pylori Infection, Dyspepsia and Peptic Ulcer Disease, sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. Completed at 1 site in Bangladesh. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Phase 4, Interventional, and Treatment
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.
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:
372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.
This study's enrollment of 80 is below the median of 89 across 302 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh is the lead sponsor of 128 studies on the registry; 22 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
S. creatinine > 2 mg/dl > 2 x
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arms will receive vonoprazan based levofloxacin containing triple therapy for 14 days
Drug: vonoprazan-based triple therapy (VAL regimen)
Participants in this arms will receive esomeprazole based levofloxacin containing triple therapy for 14 days
Drug: Esomeprazole-based triple therapy (EAL 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
Esomeprazole 20 mg twice daily (30 minutes before meal), Amoxicillin 1 g twice daily (After meal), Levofloxacin 500 mg once daily for 14 days
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.
Time frame: 4 weeks after completion of 14-day therapy
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: End of therapy (14 days)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: starting 12 months after publication
Access criteria: De-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request to the corresponding author after publication. Data will be shared with researchers who provide a methodologically sound research proposal for analyses consistent with the objectives of the original study. Requests will be reviewed by the principal investigator to ensure scientific validity and ethical compliance. Data will be provided in anonymized format through secure electronic transfer. Supporting documents, including the study protocol and statistical analysis plan, may also be made available upon request.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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