Metronidazole- Versus Tinidazole-Based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metronidazole, Tinidazole 500mg, tetracyline, Bismuth Subcitrate.
- Who it may be relevant to
- Registry conditions: Helicobacter Pylori Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Metronidazole- and Tinidazole-Based Bismuth Quadruple Regimens for Helicobacter Pylori Eradication
Overview
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
- Drug Metronidazole
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. - Drug Tinidazole 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. - Drug tetracyline
Tetracyline 500 mg four times daily - Drug Bismuth Subcitrate
120 mg four times daily - Drug esomeprazole 40 mg
40 mg twice daily
Primary outcome measures
- Helicobacter pylori Eradication Rate [Time frame: At least 4 weeks after completion of the 14-day eradication treatment]
Secondary outcome measures (1)
- Side effects [Time frame: During the 14-day eradication treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Vietnam · 1 center
- University of Medicine and Pharmacy at Ho Chi Minh City — Ho Chi Minh City
Identifiers
NCT: NCT07746934 · 2814/ĐHYD-HĐĐĐ