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NOT YET RECRUITING
NCT07746934
NA

Metronidazole- Versus Tinidazole-Based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication

Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

DRUG

tetracyline

Tetracyline 500 mg four times daily

DRUG

Bismuth Subcitrate

120 mg four times daily

DRUG

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