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Comparison of Vonoprazan-Amoxicillin versus Lansoprazole-Amoxicillin Dual Therapy for Treatment-Resistant H. pylori

Comparison of Vonoprazan-Amoxicillin versus Lansoprazole-Amoxicillin Dual Therapy for Treatment-Resistant Helicobacter pylori Infection: A Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251010067573N1
Enrollment
160
Registered
2025-11-10
Start date
2025-11-16
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection. Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere

Interventions

Intervention 1: Intervention group: This group will receive the dual therapy regimen consisting of Vonoprazan and Amoxicillin. The Vonoprazan dose is 20 milligrams, twice daily , and the Amoxicillin d

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age 18-70 years Confirmed Helicobacter pylori infection by stool antigen test and/or rapid urease test and/or gastric biopsy Failure to respond to at least one previous standard first-line H. pylori eradication regimen (treatment-resistant H. pylori) Written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Known allergy to vonoprazan, lansoprazole, amoxicillin, or other proton pump inhibitors Pregnancy or lactation History of gastric surgery Severe hepatic or renal disease Use of antibiotics or proton pump inhibitors in the last 4 weeks Gastrointestinal malignancy or inflammatory bowel disease Unwillingness to continue cooperation during the study

Design outcomes

Primary

MeasureTime frame
The primary outcome variable of the study is the frequency of Helicobacter pylori eradication. Successful eradication is defined as a negative Stool Antigen Test result during the post-treatment follow-up. Timepoint: The primary outcome variable (Helicobacter pylori eradication) will be measured four weeks after completion of the treatment period. Method of measurement: The primary outcome variable will be measured using the Stool Antigen Test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoumeh Rabbani

Kerman University of Medical Sciences

Mohammadmahdi8754@gmail.com+98 34 3261 8239

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026