A Phase 4 interventional study of Tetracycline, Metronidazole, Bismuth subcitrate and Amoxicillin, Metronidazole, Clarithromycin in Helicobacter Pylori Infection, sponsored by Mackay Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-04.
Sponsored by Mackay Memorial Hospital · Phase 4, Interventional, and Treatment
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.
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.
Mackay Memorial Hospital is the lead sponsor of 118 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be excluded from the study if any one of the following criteria is present:
Intraluminal Therapy for Helicobacter pylori Infection - Single dose medicament containing Tetracycline 2g, Metronidazole 2g, and Bismuth subcitrate 480 mg
Drug: Tetracycline, Metronidazole, Bismuth subcitrate
Intraluminal Therapy for Helicobacter pylori Infection - Single dose medicament containing Amoxicillin 3g, Metronidazole 2g, and Clarithromycin 1g
Drug: Amoxicillin, Metronidazole, Clarithromycin
52 participants (Group A) are randomly assigned to receive intraluminal eradication of H. pylori with medicament containing Tetracycline, Metronidazole, and Bismuth subcitrate
Also known as: Bismuth Trioxide
52 participants (Group B) are randomly assigned to receive intraluminal eradication of H. pylori with medicament containing Amoxicillin, Metronidazole, and Clarithromycin
Also known as: Klaricid
The eradication rates of intraluminal therapy
To evaluate and compare the eradication rates of different medicaments for the Intraluminal Therapy for Helicobacter pylori Infection between Group A and Group B.
Time frame: C13-UBT will be used to assess the existence of H. pylori 2 weeks after the intraluminal therapy
The adverse events of intraluminal therapy
of different medicaments for the Intraluminal Therapy for Helicobacter pylori Infection between Group A and Group B.
Time frame: Within one week after the Intraluminal Therapy for Helicobacter pylori Infection
The eradication rates of oral antibiotic rescue therapies
To evaluate and compare the eradication rates of different oral antibiotic rescue therapies for failed Intraluminal Therapy between concomitant therapy ( Group A) and bismuth-based quadruple therapy (Group B)
Time frame: C13-UBT will be used to assess the existence of H. pylori 4 weeks after the oral antibiotics rescue therapy
The adverse events of oral antibiotic rescue therapies
To evaluate and compare the adverse events of different oral antibiotic rescue therapies for failed Intraluminal Therapy between concomitant therapy ( Group A) and bismuth-based quadruple therapy (Group B)
Time frame: Within one week after complete the oral antibiotics rescue therapy
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mackay Memorial Hospital