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โ† Trials
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Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment

RecruitingPhase 4Ages 18 Years - 75 YearsAllYongquan Shi
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Bismuth
  • Esomeprazole
  • Tetracycline
  • Furazolidone
  • Saccharomyces Boulardii Oral Powder
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Where

1 site
Xijing Hosipital of Digestive Disease
Xi'an, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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