Efficacy And Safety of Bismuth-Tetracycline-Rabeprazole Triple Versus Bismuth Quadruple Therapies For First-Line Eradication of Helicobacter Pylori Infection: A Single-Center, Randomized Controlled Trial
| Registry | NCT07788053 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 300 (Estimated) |
| Sponsor | Chih-An Shih, MD (Other) |
| Conditions | Helicobatcer Pylori, First-Line Eradication |
| Interventions | Bismuth, Bismuth quadruple therapy (Drug) |
| Dates | start 2026-09-01 (estimated), primary completion 2029-09-01 (estimated), completion 2029-09-01 (estimated), first posted 2026-08-26, last updated 2026-08-26 |
| Locations | 1 site in Taiwan |
Related Papers Related Patents Related Grants Related Experts
All trials for Helicobatcer Pylori All trials for First-Line Eradication All trials of Bismuth All trials of Bismuth quadruple therapy
Most international treatment guidelines currently recommend a 14-day bismuth quadruple therapy as the first-line treatment for Helicobacter pylori infection, especially in areas with high clarithromycin resistance. While this therapy boasts good eradication rates, its administration is complex and has a high incidence of adverse reactions. However, tetracycline is one of the most effective anti-Helicobacter pylori antibiotics, with a resistance rate of less than 3%. This study prospectively evaluates the efficacy and safety of a 14-day triple therapy (high-dose tetracycline combined with bismuth and PPI) versus a 14-day bismuth quadruple therapy as first-line eradication therapy. This novel single-antibiotic therapy has the potential to become a new standard of care for Helicobacter pylori eradication.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Bismuth-Tetracycline-Rabeprazole Triple Therapy | Active comparator | Drug: Bismuth; Drug: Bismuth quadruple therapy | Bismuth、Tetracycline、Rabeprazole |
| Bismuth Quadruple Therapy | Active comparator | Drug: Bismuth; Drug: Bismuth quadruple therapy | Bismuth、Tetracycline、Rabeprazol、Metronidazole |
Sex: All, ages: 18 Years to 90 Years
Inclusion Criteria: adult patients (aged ≥18 years) who underwent esophagogastroduodenoscopy for the evaluation of gastrointestinal symptoms at Antai Tian-Sheng Memorial Hospital. Eligible individuals were invited to participate in an H. pylori screening program. Those who met either of the following criteria were considered for enrollment: (1) positive results from both the rapid urease test and histology, or (2) a positive culture result. Exclusion Criteria: (1) previous H. pylori eradication therapy, (2) a history of gastrectomy, (3) allergy to any of the eradication medications used in this study, (4) antibiotic use within 4 weeks before treatment, (5) the absence of post-treatment assessment for H. pylori eradication.
| Facility | City | Country | Status |
|---|---|---|---|
| Antai Medical Care Corporation, Antai Tian-Sheng Memorial Hospital | Pingtung City | Taiwan |