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

NCT07746934 | Not Yet Recruiting DMC

• 1 other identifier: 2814/ĐHYD-HĐĐĐ
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori Eradication Rate

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

Secondary Outcomes (1)

• Side effects

  During the 14-day eradication treatment

Study Arms (2)

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

Interventions

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.

Metronidazole-Based Bismuth Quadruple Therapy

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.

Tinidazole-Based Bismuth Quadruple Therapy

tetracyline DRUG

Tetracyline 500 mg four times daily

Metronidazole-Based Bismuth Quadruple Therapy; Tinidazole-Based Bismuth Quadruple Therapy

Bismuth Subcitrate DRUG

120 mg four times daily

Metronidazole-Based Bismuth Quadruple Therapy; Tinidazole-Based Bismuth Quadruple Therapy

esomeprazole 40 mg DRUG

40 mg twice daily

Metronidazole-Based Bismuth Quadruple Therapy; Tinidazole-Based Bismuth Quadruple Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

University of Medicine and Pharmacy at Ho Chi Minh City

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

Location

MeSH Terms

Interventions

Metronidazole; Tinidazole; bismuth tripotassium dicitrate; Esomeprazole

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: August 5, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): August 27, 2027
• Study Completion (Estimated): December 27, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)