Adding Saccharomyces boulardii to bismuth quadruple therapy for H. pylori rescue
Efficacy and Safety of Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: A Prospective, Multicenter, Randomized Controlled Trial
This tests whether adding the probiotic Saccharomyces boulardii to bismuth-containing quadruple therapy helps adults whose H. pylori infection did not clear after prior treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1248 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Xijing Hospital of Digestive Diseases Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT07139366 on ClinicalTrials.gov |
What this trial studies
Adults aged 18–75 with confirmed failure of prior H. pylori eradication are randomized to receive either bismuth-containing quadruple therapy alone or the same regimen plus Saccharomyces boulardii for 14 days. The regimen includes bismuth, esomeprazole, tetracycline and furazolidone, with the probiotic given as oral powder in the experimental arm. Patients are screened, receive a randomization visit on Day 0, an end-of-treatment visit around Day 14–16, and a follow-up visit about 28 days after treatment completion. Eradication is confirmed at follow-up by urea breath test, rapid urease test, or H. pylori stool antigen test.
Who should consider this trial
Good fit: Adults 18–75 with documented failure of prior H. pylori eradication, who are not pregnant or breastfeeding and who have not previously used tetracycline and furazolidone for H. pylori eradication, are ideal candidates.
Not a fit: Patients with prior use of tetracycline or furazolidone for H. pylori, substantial organ impairment, recent use of PPIs/antibiotics/bismuth, pregnancy or lactation, prior upper GI surgery, or other listed exclusions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding Saccharomyces boulardii could increase H. pylori eradication rates and reduce recurrence or treatment-related symptoms for patients who failed earlier therapies.
How similar studies have performed: Previous trials of Saccharomyces boulardii as an adjunct to H. pylori regimens have shown modest improvements in eradication rates and symptom reduction, but results are mixed and this exact combination has limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patients who have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori. * Contraindications to study drugs. * Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease. * Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening). * Pregnant or lactating women. * Underwent upper gastrointestinal Surgery. * Dysphagia. * Evidence of bleeding or iron efficiency anemia. * A history of malignancy. * Drug or alcohol abuse history in the past 1 year. * Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). * Mental disorder. * Enrolled in other clinical trials in the past 3 months. * Refuse to sign informed consent.
Where this trial is running
Xi'an, Shaanxi
- Xijing Hosipital of Digestive Disease — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Yongquan Shi
- Email: shiyquan@fmmu.edu.cn
- Phone: 86-29-84771515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.