Health TrialsbyHealthPanel

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

ConditionHelicobacter Pylori Infection
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Metronidazole-Based Bismuth Quadruple TherapyActive comparator 4 interventions
Group B: Tinidazole-Based Bismuth Quadruple TherapyExperimental treatment 4 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Medicine and Pharmacy at Ho Chi Minh City

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: