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Metronidazole- Versus Tinidazole-Based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication
Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Summary
This randomized, open-label clinical trial will compare two bismuth-containing quadruple therapies for the first-line treatment of Helicobacter pylori infection. Adults aged 18 years or older with confirmed H. pylori infection who have not previously received eradication treatment will be randomly assigned in a 1:1 ratio to receive either a metronidazole-based regimen or a tinidazole-based regimen for 14 days. Both regimens will also include esomeprazole, tetracycline, and bismuth subcitrate. The main purpose of the study is to determine whether the tinidazole-based regimen is not inferior to the metronidazole-based regimen in achieving successful H. pylori eradication. Eradication will be assessed after treatment using a carbon-13 urea breath test or an endoscopic urease test. The study will also compare adverse effects and treatment tolerability between the two groups. The results may help clinicians select the more appropriate nitroimidazole for bismuth quadruple therapy in routine clinical practice.
Official title: Comparison of Metronidazole- and Tinidazole-Based Bismuth Quadruple Regimens for Helicobacter Pylori Eradication
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2026-07-27
Completion Date
2027-12-27
Last Updated
2026-08-05
Healthy Volunteers
No
Conditions
Interventions
Metronidazole
Metronidazole 500 mg orally three times daily after meals for 14 days, administered as part of bismuth quadruple therapy with esomeprazole 40 mg twice daily, tetracycline 500 mg four times daily, and bismuth subcitrate 120 mg four times daily.
Tinidazole 500mg
Tinidazole 500 mg orally three times daily after meals for 14 days, administered as part of bismuth quadruple therapy with esomeprazole 40 mg twice daily, tetracycline 500 mg four times daily, and bismuth subcitrate 120 mg four times daily.
tetracyline
Tetracyline 500 mg four times daily
Bismuth Subcitrate
120 mg four times daily
esomeprazole 40 mg
40 mg twice daily
Locations (1)
University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh, Vietnam