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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

About this trial

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.

Eligibility criteria

Qualifiers

Adults aged 18 years or older.

Confirmed Helicobacter pylori infection

Willing and able to provide written informed consent.

Disqualifiers

Pregnancy or breastfeeding.

Gastrointestinal malignancy.

Previous H. pylori eradication therapy.

Liver cirrhosis.

Trial design

Treatments tested in this trial

  • Metronidazole
  • Tinidazole 500mg
  • tetracyline
  • Bismuth Subcitrate
  • esomeprazole 40 mg

Treatment groups

600 Participants
are divided into 2 treatment groups