NCT07139366 Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment
| NCT ID | NCT07139366 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Yongquan Shi |
| Condition | Gastritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,248 participants |
| Start Date | 2025-10-28 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,248 participants in total. It began in 2025-10-28 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07139366 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Gastritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07139366 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07139366 currently recruiting?
Yes, NCT07139366 is actively recruiting participants. Contact the research team at shiyquan@fmmu.edu.cn for enrollment information.
Where is the NCT07139366 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT07139366 clinical trial?
NCT07139366 is sponsored by Yongquan Shi. The trial plans to enroll 1,248 participants.