Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dyspepsia | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastritis | — | UNRESOLVED | — |
| Helicobacter Pylori Infection | — | UNRESOLVED | — |
| Peptic Ulcer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bismuth | Drug | — | UNRESOLVED |
| Esomeprazole | Drug | — | UNRESOLVED |
| Furazolidone | Drug | — | UNRESOLVED |
| Saccharomyces Boulardii Oral Powder | Drug | — | UNRESOLVED |
| Tetracycline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Saccharomyces boulardii combined with Bismuth-containing quadruple therapy
- description
- Saccharomyces boulardii powder 500 mg twice daily for 14 days#Tetracycline 500mg three time daily for 14 days#furazolidone 100 mg, esomeprazole 20 mg, and Bismuth 220mg by mouth, twice daily for 14 days.
- interventionNames
- Drug: Bismuth
- Drug: Esomeprazole
- Drug: Tetracycline
- Drug: Furazolidone
- Drug: Saccharomyces Boulardii Oral Powder
- type
- ACTIVE_COMPARATOR
- label
- Bismuth-containing quadruple therapy
- description
- Tetracycline 500mg three time daily for 14 days#furazolidone 100 mg, esomeprazole 20 mg, and Bismuth 220mg by mouth, twice daily for 14 days.
- interventionNames
- Drug: Bismuth
- Drug: Esomeprazole
- Drug: Tetracycline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available