Intraluminal Metronidazole 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 Metronidazole 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 Metronidazole powder (2 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 triple therapy which contains a proton pump inhibitor and two antibiotics (
      amoxicillin and metronidazole) for 14 days. C13UBT 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): Metronidazole; Lansoprazole, Amoxicillin, Metronidazole
Intervention type(s): Drug; Drug
Intervention description(s): Twenty patients receive intraluminal Metronidazole eradication of H. pylori.; Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic triple therapy which contains Lansoprazole, Amoxicillin and Metronidazole for 14 days.
Other intervention name(s): Flagyl; Takepron, Supercillin, Flagyl
Intervention MeSH terms: Amoxicillin; Metronidazole; Lansoprazole; Dexlansoprazole
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 triple therapy which contains a proton pump inhibitor and two antibiotics (amoxicillin, and metronidazole) for 14 days.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lansoprazole, Amoxicillin, Metronidazole