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

NCT07537634 | Recruiting Phase 4

• 1 other identifier: BSMMU/2024/3276
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Helicobacter Pylori Infection; Dyspepsia; Peptic Ulcer Disease; Helicobacter Pylori; H Pylori

Keywords

Helicobacter pylori; Helicobacter pylori eradication; Vonoprazan; Esomeprazole; Levofloxacin; Triple therapy; Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Endoscopic Mucosal Healing rate

  4 weeks after completion of therapy.

• Change in dyspeptic symptom severity score

  4 weeks after completion of 14-day therapy

• Adverse Events

  During therapy and up to 4 weeks after therapy completion

• Compliance to Therapy

  End of therapy (14 days)

Study Arms (2)

Vonoprazan-based triple therapy (VAL)

EXPERIMENTAL

Participants in this arms will receive vonoprazan based levofloxacin containing triple therapy for 14 days

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

Drug: Esomeprazole-based triple therapy (EAL regimen)

Interventions

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

Vonoprazan-based triple therapy (VAL)

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

Esomeprazole-based triple therapy (EAL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Dyspeptic patients with positive for both rapid urease test and stool antigen test
• Patients giving written informed consent

You may not qualify if:

• 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
• 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:
• S. creatinine \> 2 mg/dl SGPT \> 2 x Upper limit of normal

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (2)

Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

NOT YET RECRUITING

Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

RECRUITING

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Dyspepsia; Peptic Ulcer

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Syeda Mubashsharah Mahfuz, MBBS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Syeda Mubashsharah Mahfuz, MBBS

CONTACT

+8801756395139; mubashsharah68dmc@gmail.com

Md. Ahid Iqbal Khokan, MBBS, MD

CONTACT

+8801722787487; ahidiqbaldmc65@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Officer (Resident)

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 17, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): August 14, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

BA (2)