Intraluminal Therapy for Helicobacter Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Helicobacter pylori (H. pylori) is the most common chronic bacterial infection in humans.

      The prevalence of H. pylori is about 30~50% in the Western adult population. It is estimated
      that about 50% of people are infected with this bacterium in Taiwan. Many studies have shown
      that H. pylori is an important causal factor of chronic gastritis, peptic ulcer disease,
      gastric cancer and gastric lymphoma. The World Health Organization classified H. pylori as a
      Group 1 carcinogen in 1994. Endoscopic examination is indicated to confirm the above
      diagnosis for patient with H. pylori infection. Eradication of H. pylori infection reduces
      the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication
      rate of clarithromycin-based triple therapy has been declining in recent years, probably
      related to the increasing resistant rate to clarithromycin. Several strategies have been
      proposed to overcome the declining eradication rate, including (1) extending the treatment
      duration of triple therapy to 14 days; (2) the use of bismuth quadruple therapy which
      contains bismuth, a proton pump inhibitor, and two antibiotics (usually metronidazole and
      tetracycline); (3) non-bismuth quadruple therapy (concomitant therapy) which contains a
      proton pump inhibitor and three antibiotics (usually amoxicillin, metronidazole, and
      clarithromycin); (4) sequential therapy which contains a proton pump inhibitor (PPI) plus
      amoxicillin for five days, followed by a PPI plus clarithromycin and tinidazole for another
      five days. The investigators aim to improve the eradication rate of H. pylori infection while
      an endoscopic examination is performed.
    

Detailed description: 
      During the endoscopic examination, patient is sedated with intravenous Dormicum 5mg
      (5mg/1ml/amp), the vital signs will be closely monitored by physiological monitor (PHILIPS
      SureSigns VM6). The treatment will be terminated immediately if unstable vital sign detected
      or if patient asks for termination. With endoscope apparatus, the gastric mucous is irrigated
      with acetylcysteine solution and the pH value of gastric juice will be measured with the pH
      test strips before irrigation and after irrigation. The investigators dispense medicaments
      containing three kinds of antibiotics powder (Amoxicillin 3 gm、Metronidazole 2 gm and
      Clarithromycin 1 gm) on the surface of gastric mucosa and duodenal mucosa of duodenal bulb as
      evenly as possible. After the intraluminal therapy, patients will rest for 30 to 60 minutes
      and go home if the effect of sedation subsided. Patients can take meal if no abdominal
      discomfort. Patients will receive tests for serum Helicobacter pylori immunoglobulin G, liver
      function and renal function 3 to 7 days after the intraluminal therapy. C13-Urea breath test
      (UBT) will be used to assess the existence of H. pylori 6 weeks after the intraluminal
      therapy. Stool H. pylori Antigen will be used to assess the short term recurrence of H.
      pylori 4-6 months after successful intraluminal therapy . Patients fail to achieve
      intraluminal eradication of H. pylori will be randomly assigned to the oral antibiotics
      rescue therapies with standard triple therapy for either 7 days (Group A) or 14 days (Group
      B). C13-UBT will be used to assess the existence of H. pylori 6 weeks after the rescue triple
      therapy. Overall eradication rates after the first line intraluminal therapy and the oral
      antibiotics rescue therapies will be evaluated.
    

Intervention name(s): Lansoprazole; Amoxicillin; Clarithromycin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Group A: lansoprazole 30 mg b.i.d. for 7 days Group B: lansoprazole 30 mg b.i.d. for 14 days; Group A: amoxicillin 1 g b.i.d. for 7 days Group B: amoxicillin 1 g b.i.d. for 14 days; Group A: clarithromycin 500 mg b.i.d. for 7 days Group B: clarithromycin 500 mg b.i.d. for 14 days
Other intervention name(s): Takepron; Supercillin; Klaricid
Intervention MeSH terms: Amoxicillin; Clarithromycin; Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A: 7-day triple therapy for patients fail to achieve intraluminal eradication Group B: 14-day triple therapy for patients fail to achieve intraluminal eradication
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Helicobacter Infection; Eradication therapy; Antibiotics