drugset / Trial / NCT07139366

Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment

NCT07139366

Phase 4 Recruiting 1248 enrolled Yongquan Shi
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims at evaluating efficacy and safety of Saccharomyces boulardii combined with bismuth-containing quadruple Therapy versus bismuth-containing quadruple Therapy(bismuth#esomeprazole#tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that Saccharomyces boulardii combined with bismuth-containing quadruple Therapy is superior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Timeline

Start
2025-10-28
Primary completion
2026-09
Completion
2026-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Saccharomyces Boulardii Oral Powder Unknown 500 mg Oral
Background Bismuth Potassium Citrate Unknown 220 mg Oral
Background Esomeprazole Small molecule 20 mg Oral
Background Furazolidone Small molecule 100 mg Oral
Background Tetracycline Unknown 500 mg Oral