Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorXiuli Zuo

About this trial

Helicobacter pylori (H. pylori) infection, a prevalent global infectious disease, is a significant contributor to gastric cancer and other morbidities, imposing a substantial disease burden. With the rise in antibiotic resistance, the eradication of H. pylori is encountering formidable challenges. A subset of individuals, despite undergoing multiple treatment regimens, remain unable to successfully eradicate the infection. The persistence of infection in these cases could be attributed to either the limitations of detection methods leading to false positives or to the infection by superbugs that are highly resistant to antibiotics. This study is designed to ascertain whether these patients are infected with superbugs by employing various diagnostic techniques. Additionally, it aims to assess the antibiotic resistance profiles of strains associated with extremely refractory H. pylori infections through drug susceptibility testing. Based on the identified sensitivities, the study seeks to tailor treatment protocols with bismuth-containing quadruple therapy (Containing two kinds of antibiotics: sensitive antibiotic, rifabutin or high-dose metronidazole), to explore novel therapeutic strategies for patients with highly resistant H. pylori infections.

Eligibility criteria

Qualifiers

Patients aged 18-65.

Patients with H.pylori infection (Positive for rapid urease test or 13C urea breath test).

Received at least two previous standard treatment protocols for Helicobacter pylori, and the application regimens included at least three low-resistance antibiotics.

Disqualifiers

Patients with serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.

Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.

Patients with active gastrointestinal bleeding.

Patients with a history of upper gastrointestinal surgery.

Trial design

Treatments tested in this trial

  • Bismuth
  • Vonoprazan
  • Amoxicillin
  • Rifabutin
  • Metronidazole
  • Other antibiotics

Treatment groups

30 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Xiuli Zuo

Lead sponsor

Shandong University

Sponsor institution