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NCT07139366
Efficacy and Safety of Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: A Prospective, Multicenter, Randomized Controlled Trial
Phase 4 trial testing Bismuth in Gastritis in 1,248 participants. Currently enrolling.
1 September 2026
Quick facts
| Lead sponsor | Yongquan Shi |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,248 |
| Start date | 28 October 2025 |
| Primary completion | 1 September 2026 |
| Estimated completion | 1 September 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Bismuth
- Esomeprazole (esomeprazole) — full drug profile →
- Tetracycline — full drug profile →
- Furazolidone (FURAZOLIDONE) — full drug profile →
- Saccharomyces Boulardii Oral Powder
Conditions studied
- Gastritis — all drugs for Gastritis →
- Dyspepsia — all drugs for Dyspepsia →
- Helicobacter Pylori Infection — all drugs for Helicobacter Pylori Infection →
- Gastric Cancer — all drugs for Gastric Cancer →
Sponsor
Yongquan Shi — full company profile →
Who can join
Adults 18 to 75, any sex, with Gastritis or Dyspepsia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Helicobacter pylori eradication
Time frame: 28 days after treatment
The primary end point of this study is H.pylori eradication#established by negative \[13C\] urea breath test #DOB value below 3.9#28 days after the end of eradication
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07139366
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bismuth
Trials testing the same drug.
- NCT06977841 — Tegoprazan-Based Therapies for H. Pylori Eradication: A Randomized Controlled Trial · NA · completed
- NCT07068607 — Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradicatio · Phase 4 · recruiting
- NCT06731023 — Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extreme · not yet recruiting
- NCT06514274 — Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Era · Phase 4 · completed
- NCT06603688 — Study on the Efficacy and Safety of Berberine, Minocycline, Esomeprazole, and Colloidal Bismuth Quadruple Therapy in the · Phase 4 · unknown
Other recruiting trials for Gastritis
Currently open trials in the same condition.
- NCT07032961 — A Cohort Study of Mobile Capsule Gastroscopy for Gastric Pathologies Screening · recruiting
- NCT06948487 — Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis · recruiting
- NCT06848400 — Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios · NA · recruiting
Other Yongquan Shi trials
Trials by the same sponsor.
- NCT07546097 — Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis（U · Phase 4 · recruiting
- NCT07068607 — Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradicatio · Phase 4 · recruiting
- NCT06610266 — Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia · Phase 4 · recruiting
- NCT06610760 — Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia · Phase 4 · recruiting
- NCT06617182 — Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury. · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07139366 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yongquan Shi
- Last refreshed: 30 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07139366.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing