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NCT Number: NCT07746934

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older.
  • Confirmed Helicobacter pylori infection
  • Willing and able to provide written informed consent.

Exclusion criteria

  • Pregnancy or breastfeeding.
  • Gastrointestinal malignancy.
  • Previous H. pylori eradication therapy.
  • Liver cirrhosis.
  • Stage IV or V chronic kidney disease.
  • Previous gastric surgery.
  • Known allergy to any study medication.
  • Use of antibiotics within the previous 4 weeks.

Treatment and study plan

Metronidazole

Drug

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

Drug

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

Drug

Tetracyline 500 mg four times daily

Bismuth Subcitrate

Drug

120 mg four times daily

esomeprazole 40 mg

Drug

40 mg twice daily

Primary outcomes

  1. Helicobacter pylori Eradication Rate

    Time frame: At least 4 weeks after completion of the 14-day eradication treatment

Secondary outcomes

  1. Side effects

    Time frame: During the 14-day eradication treatment

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

Comparison of Metronidazole- and Tinidazole-Based Bismuth Quadruple Regimens for Helicobacter Pylori Eradication

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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