Efficacy and Safety of Vonoprazan Based Triple and Reverse Hybrid Therapies Compared with Standard Proton Pump Inhibitor Based Triple Therapy for Helicobacter pylori Eradication: A Quasi-Experimental Study

Efficacy and Safety of Vonoprazan-Based Triple and Reverse Hybrid Therapies Compared with Standard Proton Pump Inhibitor Based Triple Therapy for Helicobacter pylori Eradication: A Quasi Experimental Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

TCTR

Registry ID

TCTR20260718001

Enrollment

150

Registered

2026-07-18

Start date

2026-05-06

Completion date

Unknown

Last updated

2026-08-03

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 eradication, PCAB, Proton pump inhibitor

Interventions

Vonoprazan + amoxicillin + clarithromycin ,Vonoprazan + amoxicillin + clarithromycin + metronidazole for the first 7 days, followed by vonoprazan and amoxicillin for an additional 7 days,Omeprazole or

Treatment,Treatment,Treatment

Vonoprazan based triple therapy,Vonoprazan based reverse hybrid therapy,Standard proton pump inhibitor based triple therapy

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients of all sexes with age 18 years or more 2. Treatment naive patients (new cases) with confirmed diagnosis of H. pylori infection by stool antigen test or gastric/duodenal biopsy with H. pylori testing or rapid urease test or urea breath test 3. Patients with endoscopic findings consistent with H. pylori infection, such as Chronic active gastritis or duodenitis, Pangastritis, Uncomplicated gastric or duodenal ulcer

Exclusion criteria

Exclusion criteria: 1. Known allergy to study medications 2. Pregnant or lactating women 3. Chronic liver disease/Chronic kidney disease 4. Patients of gastric or duodenal ulcer complicated by perforation/bleeding 5. Patients with history of gastric carcinoma 6. Patients with history of QT prolongation or ventricular tachycardia/fibrillation 7. Patients unable to take oral medications (e.g. severe vomiting, intestinal obstruction) 8. No willingness to provide written informed consent

Design outcomes

Primary

Measure	Time frame
H. pylori eradication At 6 weeks after the intervention Stool H. pylori antigen, Biopsy	—

Secondary

Measure	Time frame
Adverse events, Compliance At 6 weeks after the intervention or any time during the study period for adverse events Patient reported adverse event questionnaire, Pill count, patient self reported diary	—

Countries

Nepal

Contacts

Public ContactRavi Pradhan

Maharajgunj Medical Campus, TU Teaching Hospital

drravipradhan@iom.edu.np9864041308

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026