Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy
Condition: Gastric Ulcer; Chronic Gastritis; Gastric Cancer; Helicobacter Pylori Infection; Gastritis
MeSH terms: Gastritis; Stomach Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims at evaluating efficacy and safety of berberine- amoxicillin containing
      quadruple therapy(berberine, amoxicillin, esomeprazole and bismuth) versus
      tetracycline-furazolidone quadruple therapy (tetracycline, furazolidone, esomeprazole and
      bismuth) in H. pylori rescue therapy. It is hypothesized that berberine-amoxicillin
      containing quadruple therapy is non-inferior to tetracycline-furazolidone 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.
    

Detailed description: 
      Detailed Description:

      The study will include three phases: screening, treatment and follow-up. Screening: this
      phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing
      informed consent. One of urea breath test，rapid urease test or helicobacter pylori stool
      antigen test will be performed in addition to the baseline routine evaluations.

      Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A
      randomization visit will take place on Day 0 and an end-of-treatment visit will take place
      between day 13 and 17.

      Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication
      of H. Pylori will be confirmed by one of urea breath test，rapid urease test or helicobacter
      pylori stool antigen test。
    

Intervention name(s): Berberine; Amoxicillin; Esomeprazole; Bismuth; Tetracycline; Furazolidone; Esomeprazole; Bismuth
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，esomeprazole 20 mg BID, ,and Bismuth 100 mg 2 capsules BID.; Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Amoxicillin 500 mg 2 capsules BID plus berberine 100 mg 3 tablets TID, esomeprazole 20mg 1tablet BID, and bismuth 100 mg 2 capsules BID; Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Esomeprazole 20mg 1 tablet BID plus berberine 100 mg 3 tablets TID,amoxicillin 500 mg 2 capsules BID, and bismuth 100 mg 2 capsules BID; Tetracycline-furazolidone containing quadruple therapy group: 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 100 mg 2 capsules BID; Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of Tetracycline 250mg 2 capsulesTID plus furazolidone 100mg 1 tablets BID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID; Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus Tetracycline 250mg 2 capsulesTID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID; Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of esomeprazole 20 mg 1 tablets BID plus Tetracycline 250mg 2 capsules TID, furazolidone 100mg 1 tablets BID， and bismuth 100 mg 2 capsules BID; Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of bismuth 100 mg 2 capsules BID plus Tetracycline 250mg 2 capsules TID ，furazolidone 100mg 1 tablets BID and esomeprazole 20 mg 1 tablets BID
Other intervention name(s): Amoxy; Nexium; Nexium
Intervention MeSH terms: Amoxicillin; Tetracycline; Furazolidone; Esomeprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment