drugset / Trial / NCT05237115
Helicobacter Pylori Eradication With Probiotics Combined With Triple Therapy Versus Bismuth-containing Quadruple Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims at evaluating efficacy and safety of probiotics combined with triple therapy (Clostridium butyricum capsule and Bacillus coagulans tablets, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori eradication. It is hypothesized that probiotics combined with triple therapy is non-inferior to bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.
Timeline
- Start
- 2020-05-05
- Primary completion
- 2020-12-05
- Completion
- 2020-12-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bacillus coagulans | Other / unclassified | 350 mg | — |
| Subject | Clostridium butyricum | Other / unclassified | 420 mg | — |
| Comparator | colloidal bismuth tartrate | Unknown | 55 mg | — |
| Background | Amoxicillin | Other / unclassified | 500 mg | — |
| Background | Clarithromycin | Small molecule | 500 mg | — |
| Background | Esomeprazole | Small molecule | 40 mg | — |