Status:
RECRUITING
Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment
Lead Sponsor:
Yongquan Shi
Conditions:
Gastritis
Dyspepsia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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#tetracy...
Detailed Description
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
1248 Patients enrolled
Trial Details
Trial ID
NCT07139366
Start Date
October 28 2025
End Date
September 1 2026
Last Update
December 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China, 710032