Actively Recruiting
Efficacy and Safety of Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: A Prospective, Multicenter, Randomized Controlled Trial
Led by Yongquan Shi · Updated on 2025-12-02
1248
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender.
- Patients with confirmed failure of previous Helicobacter pylori eradication therapies.
- Women not pregnant or nursing, and if of childbearing potential, must use acceptable contraception during the study and 30 days after.
You will not qualify if you...
- Previous use of tetracycline and furazolidone antibiotics for H. pylori infection.
- Contraindications to study drugs.
- Severe or unstable heart, lung, or endocrine diseases.
- Regular use of anti-ulcer drugs, antibiotics, or bismuth complexes shortly before screening.
- Pregnant or breastfeeding women.
- History of upper gastrointestinal surgery.
- Difficulty swallowing.
- Evidence of bleeding or iron deficiency anemia.
- History of cancer.
- Drug or alcohol abuse in the past year.
- Use of systemic corticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, or platelet inhibitors (except low-dose aspirin).
- Mental disorders.
- Participation in other clinical trials in the past 3 months.
- Refusal to sign informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility evaluation and baseline tests including breath, rapid urease, or stool antigen tests
Duration - 14 days
Participants receive assigned medication therapy for Helicobacter pylori eradication.
1 randomization visit on Day 0 and 1 end-of-treatment visit between Day 14 and 16
Duration - Approximately 28 days after treatment ends
Participants are assessed for Helicobacter pylori eradication and safety after treatment completion.
1 follow-up visit to confirm eradication using breath, rapid urease, or stool antigen tests
Trial Site Locations
Total: 1 location
1
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
Y
Yongquan Shi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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