Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYongquan Shi

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

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

Treatment groups

1,248 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yongquan Shi

Lead sponsor

Xijing Hospital of Digestive Diseases

Sponsor institution