University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam
NCT Number: NCT07746934
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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 500 mg four times daily
120 mg four times daily
40 mg twice daily
Time frame: At least 4 weeks after completion of the 14-day eradication treatment
Time frame: During the 14-day eradication treatment
University of Medicine and Pharmacy at Ho Chi Minh City
Other
Comparison of Metronidazole- and Tinidazole-Based Bismuth Quadruple Regimens for Helicobacter Pylori Eradication
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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