Helicobacter Pylori Eradication With Probiotics Combined With Triple Therapy Versus Bismuth-containing Quadruple Therapy
Condition: Gastritis; Peptic Ulcer; Dyspepsia
MeSH terms: Gastritis; Peptic Ulcer; Dyspepsia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims at evaluating efficacy and safety of probiotics combined with triple therapy
      (Clostridium butyricum capsule and Bacillus coagulans tablets, esomeprazole, clarithromycin
      and amoxicillin) versus bismuth-containing quadruple therapy
      (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori eradication. It is
      hypothesized that probiotics combined with triple therapy is non-inferior to
      bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status will
      be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a
      urea breath test(UBT) will be performed to confirm eradication.
    

Detailed description: 
      The study will include three phases: screening, treatment and follow-up. Screening: this
      phase will last a maximum of 28 days and subjects eligibility will be evaluated after
      informed consent signature. Urea Breath 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 12 and 14.

      Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end
      of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).
    

Intervention name(s): Clostridium butyricum capsule; esomeprazole; amoxicillin; clarithromycin; Bacillus clotting; Bismuth
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Clostridium butyricum group: given for 14 days at a dose of Clostridium butyricum capsule 420mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.; Esmeprazole 40mg 1tablet BID plus amoxicillin 500 mg 2 capsules BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.; Amoxicillin 500 mg 2 capsules BID plus esmeprazole 40mg 1tablet BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.; Clarithromycin 500 mg 1 tablet BID plus amoxicillin 500 mg 2 capsules BID, esmeprazole 40mg 1tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.; given for 14 days at a dose of Bacillus coagulans tablets 350mg 3 capsules, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.; given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
Other intervention name(s): Nexium; Amoxy ( Uni-Amocin ); Bitnal
Intervention MeSH terms: Amoxicillin; Clarithromycin; Esomeprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Probiotics-combining triple therapy; Bismuth-combining quadruple therapy