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Comparing of treatment outcome between 14-day Vonoprazan-Amoxicillin dual therapy and high-dose Omeprazole-Amoxicillin plus Bismuth therapy for first-line Helicobacter pylori eradication: a multicenter randomized controlled trial

Comparing of treatment outcome between 14-day Vonoprazan-Amoxicillin dual therapy and high-dose Omeprazole-Amoxicillin plus Bismuth therapy for first-line Helicobacter pylori eradication: a multicenter randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251120002
Enrollment
264
Registered
2025-11-20
Start date
2025-01-01
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 remains highly prevalent, and the effectiveness of standard triple therapy has declined due to increasing clarithromycin resistance in Thailand and many Asian regions. Although Vonoprazan based dual therapy has shown high eradication rates, its clinical use is limited by cost and lack of availability within the national essential drug list. High-dose omeprazole and Amoxicillin therapy with added Bismuth may offer a similarly effective but more accessible alternative

Interventions

Omeprazole 40 mg BID plus Amoxicillin 1 g TID plus Bismuth 1048 mg BID for 14 days.,Vonoprazan 20 mg BID plus Amoxicillin 1 g TID for 14 days.
Experimental Drug,Experimental Drug
High dose Omeprazole-Amoxicillin plus Bismuth,Vonoprazan-Amoxicillin dual therapy

Sponsors

Department of internal medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Confirmed H. pylori infection by histology, rapid urease test, urea breath test, or stool antigen test 2. No prior eradication therapy

Exclusion criteria

Exclusion criteria: 1. History of previous Helicobacter pylori treatment 2. History of chronic and severe underlying diseases, such as liver disease, chronic renal failure, or advanced malignancy 3. History of gastric cancer 4. History of allergy to any study medications, including Penicillin or Salicylate group drugs 5. Pregnant or breastfeeding women 6. History of using medications that may interact with the study drugs, such as Clopidogrel or Warfarin

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication 6 weeks post-treatment. 6 weeks Stool antigen test or urea breath test

Secondary

MeasureTime frame
Adverse events during treatment 2 weeks clinical,Medication adherence during treatment 2 weeks percent of medication adherence

Countries

Thailand

Contacts

Public Contactpornrawin krathong

Rajavithi hospital

benz.pornrawin@gmail.com022062900

Outcome results

None listed

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