Intraluminal Amoxicillin Powder Monotherapy for Helicobacter Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; 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 evaluate the efficacy of Amoxicillin powder in the
      Intraluminal therapy for Helicobacter 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. Patients will receive test for UFT300 to evaluate H.
      pylori colonization in the gastric cardia. 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 Amoxicillin powder in the capsule (3 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. C13-Urea breath test (UBT) will
      be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy. Patients
      fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic
      rescue therapies with High-dose PPI-amoxicillin dual therapy (rabeprazole 20 mg and
      amoxicillin 750 mg 4 times/day) for 14 days. C13-UBT will be used to assess the existence of
      H. pylori 6 weeks after the rescue therapy. Overall eradication rates after the first line
      intraluminal therapy and the oral antibiotics rescue therapies will be evaluated.
    

Intervention name(s): Amoxicillin; Rabeprazole, Amoxicillin
Intervention type(s): Drug; Drug
Intervention description(s): Twenty patients receive Intraluminal Amoxicillin eradication for H. pylori.; Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic rescue therapies with high dose dual therapy (Rabeprazole, Amoxicillin) for 14 days.
Other intervention name(s): Supercillin; Pariet, Supercillin
Intervention MeSH terms: Amoxicillin; Rabeprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: 20 participants receive intraluminal eradication of H. pylori. Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic rescue therapies with High-dose PPI-amoxicillin dual therapy (rabeprazole 20 mg and amoxicillin 750 mg 4 times/day) for 14 days.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rabeprazole; Amoxicillin; Helicobacter Pylori