NCT07139366RecruitingPhase 4
Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment
Efficacy and Safety of Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: A Prospective, Multicenter, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1248 (estimated)
- First submitted
- 12 Aug 2025
- Start date
- 28 Oct 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Yongquan Shi
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07139366
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1248
- From 28 Oct 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori.
- Contraindications to study drugs.
- 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).
- Underwent upper gastrointestinal Surgery.
- Drug or alcohol abuse history in the past 1 year.
Other illness
- Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
- Evidence of bleeding or iron efficiency anemia.
- A history of malignancy.
- Mental disorder.
Lab values
- Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
Other
- Pregnant or lactating women.
- Dysphagia.
- Enrolled in other clinical trials in the past 3 months.
- Refuse to sign informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xijing Hosipital of Digestive Disease Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.