Actively Recruiting
Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment
Led by Yongquan Shi · Updated on 2025-12-02
1248
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 Helicobacter pylori eradication therapies
- Women must not be pregnant or nursing and must use acceptable contraception during the study and for 30 days after
You will not qualify if you...
- Previous use of tetracycline and furazolidone antibiotics for Helicobacter pylori infection
- Contraindications to study drugs
- Severe or unstable organ, cardiopulmonary, or endocrine diseases
- Regular use of anti-ulcer drugs, antibiotics, or bismuth complexes within 1 month before screening
- Pregnant or breastfeeding women
- History of upper gastrointestinal surgery
- Difficulty swallowing (dysphagia)
- Evidence of bleeding or iron deficiency anemia
- History of cancer
- Drug or alcohol abuse within the past year
- Use of systemic corticosteroids, nonsteroidal anti-inflammatory drugs, anticoagulants, or platelet inhibitors (except aspirin below 100 mg/day)
- Mental disorders
- Participation in other clinical trials within the past 3 months
- Refusal to sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
Y
Yongquan Shi
CONTACT
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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