Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Dyspepsia; Helicobacter Pylori Infection; Helicobacter Pylori; Peptic Ulcer Disease; H Pylori
• Intervention / Treatment: Drug: vonoprazan-based triple therapy (VAL regimen); Drug: Esomeprazole-based triple therapy (EAL regimen)

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Syeda Mubashsharah Mahfuz, MBBS; Phone Number: +8801756395139; Email: mubashsharah68dmc@gmail.com
• Study Contact Backup: Name: Md. Ahid Iqbal Khokan, MBBS, MD; Phone Number: +8801722787487; Email: ahidiqbaldmc65@gmail.com

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • Recruiting
    • Bangabandhu Sheikh Mujib Medical University
    • Contact: Syeda Mubashsharah Mahfuz, MBBS; Phone Number: +8801756395139; Email: mubashsharah68dmc@gmail.com
    • Contact: Md. Ahid Iqbal Khokan, MBBS, MD; Phone Number: +8801722787487; Email: ahidiqbaldmc65@gmail.com
    • Principal Investigator: Syeda Mubashsharah Mahfuz, MBBS
  • Dhaka, Bangladesh
    • Not yet recruiting
    • Bangabandhu Sheikh Mujib Medical University
    • Contact: Syeda Mubashsharah Mahfuz, MBBS; Phone Number: +8801756395139; Email: mubashsharah68dmc@gmail.com
    • Contact: Md. Ahid Iqbal Khokan, MBBS, MD; Phone Number: +8801722787487; Email: ahidiqbaldmc65@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vonoprazan-based triple therapy (VAL); Participants in this arms will receive vonoprazan based levofloxacin containing triple therapy for 14 days	Drug: 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
Active Comparator: Esomeprazole-based triple therapy (EAL); Participants in this arms will receive esomeprazole based levofloxacin containing triple therapy for 14 days	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks after completion of 14-day therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	End of therapy (14 days)

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Investigators: Principal Investigator: Syeda Mubashsharah Mahfuz, MBBS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Publications and helpful links

General 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 record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): August 14, 2026

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Levofloxacin; Dyspepsia; Triple therapy; Vonoprazan; Esomeprazole; Helicobacter pylori eradication
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Duodenal Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dyspepsia; Peptic Ulcer
• Other Study ID Numbers: BSMMU/2024/3276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: starting 12 months after publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No