Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment
Launched by YONGQUAN SHI · Aug 18, 2025
Trial Information
Current as of September 07, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to treat an infection called Helicobacter pylori (H. pylori), which can cause stomach problems like gastritis, ulcers, and sometimes increase the risk of stomach cancer. The study is testing whether adding a friendly yeast called Saccharomyces boulardii to the usual medicine combination (which includes bismuth, esomeprazole, tetracycline, and furazolidone) works better to get rid of the infection in people for whom previous treatments have not worked.
Adults between 18 and 75 years old who have tried to treat H. pylori before but were not successful might be eligible to join. Women who are pregnant or breastfeeding cannot participate, and those who can become pregnant need to use birth control during and for a month after the study. Participants will be randomly assigned to receive either the usual treatment or the usual treatment plus the yeast. After about six weeks, they will have tests like a breath, stool, or stomach test to see if the infection is gone. This study is not yet enrolling patients, but it aims to find a safer and more effective way to help people with stubborn H. pylori infections.
Gender
ALL
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.
About Yongquan Shi
Yongquan Shi is a dedicated clinical trial sponsor focused on advancing medical research and innovation. With a commitment to improving patient outcomes, the organization specializes in designing and executing clinical studies across various therapeutic areas. Yongquan Shi emphasizes rigorous scientific methodologies and ethical standards, ensuring the integrity of data and the safety of participants. Through collaboration with leading researchers and institutions, the sponsor aims to bring new therapies to market, ultimately enhancing healthcare solutions for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Xi'an, Shaanxi, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported