RecruitingPhase 4NCT07139366

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


Sponsor

Yongquan Shi

Enrollment

1,248 participants

Start Date

Oct 28, 2025

Study Type

INTERVENTIONAL

Conditions

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#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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a probiotic called Saccharomyces boulardii to a standard antibiotic treatment regimen (bismuth quadruple therapy) can improve the success rate of eliminating H. pylori — a bacteria in the stomach that causes ulcers and increases stomach cancer risk — in people who have already tried and failed previous treatments. **You may be eligible if...** - You are 18 to 75 years old - You have H. pylori infection that did not go away after prior antibiotic treatment - You are not pregnant or breastfeeding, and using appropriate contraception if of childbearing potential **You may NOT be eligible if...** - You have previously used tetracycline or furazolidone antibiotics to treat H. pylori - You are allergic to any of the study medications - You have serious heart, lung, or endocrine disease - You have been taking proton pump inhibitors (PPIs), antibiotics, or bismuth within the past month Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBismuth

Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 1 tablets BID#tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID

DRUGEsomeprazole

Bismuth-containing quadruple therapy: given for 14 days at a dose of esomeprazole 20mg 1 tablets BID plus bismuth 110 mg 2 capsules BID#tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID

DRUGTetracycline

Bismuth-containing quadruple therapy:given for 14 days at a dose of tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID#esomeprazole 20 mg 1 tablets BID and bismuth 110 mg 2 capsules BID

DRUGFurazolidone

Bismuth-containing quadruple therapy:given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus tetracycline 250mg 2 capsules TID#esomeprazole 20 mg 1 tablets BID and bismuth 110 mg 2 capsules BID

DRUGSaccharomyces Boulardii Oral Powder

Saccharomyces boulardii combined with Bismuth-containing quadruple therapy:given for 14 days at a dose of Saccharomyces boulardii powder 250 mg 2 packets BID#bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 1 tablets BID#tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID


Locations(1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, China

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NCT07139366


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