Study of Saccharomyces Boulardii Added to Bismuth Quadruple Therapy for Treating Helicobacter Pylori Infection After Previous Treatment Failure

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining Saccharomyces boulardii with bismuth-containing quadruple therapy compared to the quadruple therapy alone in patients who have not successfully eradicated Helicobacter pylori infection. This Phase 4 trial aims to determine if adding Saccharomyces boulardii improves treatment outcomes for H. pylori rescue therapy. The study has three phases screening, treatment, and follow-up. During screening, lasting up to 14 days, eligibility is confirmed with tests such as the urea breath test, rapid urease test, or stool antigen test. Participants are randomly assigned to one of two groups for 14 days of treatment one group receives Saccharomyces boulardii powder alongside standard bismuth, esomeprazole, tetracycline, and furazolidone the other group receives only the quadruple therapy drugs. Follow-up occurs about 28 days after treatment to confirm H. pylori eradication using the same diagnostic tests. Participants will undergo visits at screening, treatment start, end of treatment, and follow-up. Researchers will monitor eradication success through testing 28 days post-treatment and track any adverse events during treatment and follow-up. The total participation time includes the screening period, 14 days of treatment, and approximately one month of follow-up, ensuring detailed evaluation of therapy outcomes and safety.

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