ILTHPI - Comparison of Medicament Containing Tetracycline, Metronidazole, Bismuth Versus Amoxicillin, Metronidazole, Clarithromycin
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      Helicobacter pylori (H. pylori) is a spiral shaped, microaerophilic, gram negative bacterium.
      The organism resides in the acid and mucous layer of the human gastric mucosa, adheres to and
      colonizes the mucosal surface of the stomach and the mucosal epithelium with gastric
      metaplasia of duodenal bulb. Many studies have shown that H. pylori is an important causal
      factor of chronic gastritis, peptic ulcer disease, gastric cancer and gastric lymphoma.
      Endoscopic examination is indicated to confirm the above diagnosis for patient with H. pylori
      infection. The eradication rate of standard triple therapy has fallen below 80% in many
      countries due to the worldwide increasing prevalence of antibiotic resistant strains. This is
      related to the special gastric milieu of H. pylori, which leads to a more difficult and
      complicated treatment for achieving a successful eradication rate than other bacteria.
      Several strategies have been proposed to increase the eradication rate in the first line
      therapy or as a rescue therapy. However, these rescue therapies will increase the side
      effects and costs of treatment, decrease the compliance of patients and increase the rate of
      worldwide antibiotic resistance steadily. The WHO has listed H. Pylori as one of 12
      antibiotic-resistant bacteria that have the greatest threat to human health in Feb. 2017. Our
      previous studies suggested that the administration of single -dose therapeutic agents can
      achieve the eradication of H. pylori immediately while conducting the endoscopic examination.
      The eradication rate of intraluminal therapy for H. pylori infection (ILTHPI) is 53.7%
      (51/95), and control the intragastric pH above 4 prior to the ILTHPI can even reach a
      72.0%(36/50) eradication rate of H. pylori.

      According to the recent Taiwan consensus for the treatment of H. pylori in 2017, the first
      line therapeutic regiment of H. pylori containing Amoxicillin, Clarithromycin, and
      Metronidazole if the rate of Clarithromycin resistance is below 15%, while the first line
      therapeutic regiment of H. pylori containing tetracycline, metronidazole, and bismuth
      subcitrate if the rate of Clarithromycin resistance is above 15%. We aimed to evaluate and
      compare the efficacy of medicament containing Tetracycline, Metronidazole, and Bismuth versus
      Amoxicillin, Metronidazole, and Clarithromycin for the Intraluminal therapy of Helicobacter
      pylori infection.
    

Detailed description: 
      During the endoscopic examination, patient is sedated with intravenous Midazolam 5mg and
      Fentanyl 0.05mg, 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. The pH value of gastric juice will be measured with the
      pH test strips. and the he gastric mucus is irrigated with acetylcysteine solution. The
      investigators randomly assigned medicaments containing different antibiotic powders either
      Tetracycline 2g, Metronidazole 2g, and Bismuth 480mg (Group A) or Amoxicillin 3g,
      Metronidazole 2g, and Clarithromycin 1g (Group B) to dispense on the surface of gastric
      mucosa and duodenal mucosa of duodenal bulb. 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 2 weeks after the intraluminal therapy. Patients failed to achieve
      intraluminal eradication of H. pylori will be assigned to 7-day concomitant therapy (Group A)
      or 7-day bismuth quadruple therapy (Group B). The C13-UBT will be used to assess the
      existence of H. pylori 4 weeks after the oral antibiotic therapy. The overall eradication
      rates of the intraluminal therapy plus the oral antibiotics therapies will be evaluated.
    

Intervention name(s): Tetracycline, Metronidazole, Bismuth subcitrate; Amoxicillin, Metronidazole, Clarithromycin
Intervention type(s): Drug; Drug
Intervention description(s): 52 participants (Group A) are randomly assigned to receive intraluminal eradication of H. pylori with medicament containing Tetracycline, Metronidazole, and Bismuth subcitrate; 52 participants (Group B) are randomly assigned to receive intraluminal eradication of H. pylori with medicament containing Amoxicillin, Metronidazole, and Clarithromycin
Other intervention name(s): Bismuth Trioxide; Klaricid
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Tetracycline; Bismuth tripotassium dicitrate; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 104 participants are randomly assigned to receive intraluminal eradication of H. pylori.
with medicaments containing Tetracycline, Metronidazole, and Bismuth versus Amoxicillin, Metronidazole, and Clarithromycin.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter Pylori; Proton pump inhibitor; Amoxicillin; Metronidazole; Bismuth; Tetracycline; Clarithromycin