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

ConditionHELICOBACTER PYLORI INFECTIONS

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

This trial does not accept healthy volunteers

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 population

The study enrolled patients with extremely refractory Helicobacter pylori (H. pylori) infection, identified in the outpatient department. These patients had previously undergone eradication programs that included three antibiotics with low resistance rates: amoxicillin, tetracycline, and furazolidone. Despite this, reexamination confirmed persistent H. pylori infection. Upon entry into the study, participants were required to fulfill the inclusion criteria, not meet the exclusion criteria, and provide signed informed consent.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Bismuth
Drug
Bismuth 0.6g bid
Vonoprazan
Drug
vonoprazan 20mg bid
Amoxicillin
Drug
Amoxicillin 1g bid
Rifabutin
Drug
Rifabutin 0.15g bid
Metronidazole
Drug
Metronidazole 400mg qid
Other antibiotics
Drug
The selection of other antibiotics is based on the results of drug susceptibility testing.

Treatment groups

30 Participants

are divided into 3 treatment groups

Group A: Unsuccessful culture attempts group4 interventions

Group B: Demonstrate sensitivity to both amoxicillin and rifabutin group4 interventions

Group C: Drug susceptibility testing group6 interventions