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

NCT07746934 — Not applicable, Not yet recruiting, 600 participants, University of Medicine and Pharmacy at Ho Chi Minh City

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

Registry	NCT07746934
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	600 (Estimated)
Sponsor	University of Medicine and Pharmacy at Ho Chi Minh City (Other)
Conditions	Helicobacter Pylori Infection
Interventions	Metronidazole, Tinidazole 500mg, tetracyline, Bismuth Subcitrate, esomeprazole 40 mg (Drug)
Dates	start 2026-07-27 (estimated), primary completion 2027-08-27 (estimated), completion 2027-12-27 (estimated), first posted 2026-08-05, last updated 2026-08-05
Locations	1 site in Vietnam

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Metronidazole-Based Bismuth Quadruple Therapy	Active comparator	Drug: Metronidazole; Drug: tetracyline; Drug: Bismuth Subcitrate; Drug: esomeprazole 40 mg
Tinidazole-Based Bismuth Quadruple Therapy	Experimental	Drug: Tinidazole 500mg; Drug: tetracyline; Drug: Bismuth Subcitrate; Drug: esomeprazole 40 mg

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

+Outcome measures

Primary outcomes

Helicobacter pylori Eradication Rate [At least 4 weeks after completion of the 14-day eradication treatment]

Secondary outcomes

Side effects [During the 14-day eradication treatment]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
University of Medicine and Pharmacy at Ho Chi Minh City	Ho Chi Minh City, Ho Chi Minh	Vietnam