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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07746934

Enrollment

600

Registered

2026-08-05

Start date

2026-07-27

Completion date

2027-12-27

Last updated

2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Brief 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.

Interventions

DRUGMetronidazole

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.

DRUGTinidazole 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.

DRUGtetracyline

Tetracyline 500 mg four times daily

DRUGBismuth Subcitrate

120 mg four times daily

DRUGesomeprazole 40 mg

40 mg twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Helicobacter pylori Eradication Rate	At least 4 weeks after completion of the 14-day eradication treatment

Secondary

Measure	Time frame
Side effects	During the 14-day eradication treatment

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026