Efficacy and Safety of Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: A Prospective, Multicenter, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age between 18\

⁃ 75, both gender.

• Patients who had failed H.pylori eradication therapies .

• Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

Locations
Other Locations
China
Xijing Hosipital of Digestive Disease
RECRUITING
Xi'an
Contact Information
Primary
Yongquan Shi
shiyquan@fmmu.edu.cn
86-29-84771515
Time Frame
Start Date: 2025-10-28
Estimated Completion Date: 2026-09
Participants
Target number of participants: 1248
Treatments
Experimental: Saccharomyces boulardii combined with Bismuth-containing quadruple therapy
Saccharomyces boulardii powder 500 mg twice daily for 14 days#Tetracycline 500mg three time daily for 14 days#furazolidone 100 mg, esomeprazole 20 mg, and Bismuth 220mg by mouth, twice daily for 14 days.
Active_comparator: Bismuth-containing quadruple therapy
Tetracycline 500mg three time daily for 14 days#furazolidone 100 mg, esomeprazole 20 mg, and Bismuth 220mg by mouth, twice daily for 14 days.
Sponsors
Leads: Yongquan Shi

This content was sourced from clinicaltrials.gov