Adding Saccharomyces boulardii to bismuth quadruple therapy for H. pylori rescue

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 18–75 with confirmed failure of prior H. pylori eradication are randomized to receive either bismuth-containing quadruple therapy alone or the same regimen plus Saccharomyces boulardii for 14 days. The regimen includes bismuth, esomeprazole, tetracycline and furazolidone, with the probiotic given as oral powder in the experimental arm. Patients are screened, receive a randomization visit on Day 0, an end-of-treatment visit around Day 14–16, and a follow-up visit about 28 days after treatment completion. Eradication is confirmed at follow-up by urea breath test, rapid urease test, or H. pylori stool antigen test.

Why it matters

Who can join: the full rules

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.

Where it's running

• Xijing Hosipital of Digestive Disease
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Yongquan Shi
• Email: shiyquan@fmmu.edu.cn
• Phone: 86-29-84771515

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.