Susceptibility Testing Guided Versus Empirical Therapy for Refractory H. Pylori Infection
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
Aim: Therefore, we aimed to
1. compare the efficacy of susceptibility testing guided therapy vs. empirical therapy in
the third-line eradication for refractory H. pylori infection
2. assess the long-term impact of eradication therapy on the antibiotic resistance and
microbiota of the gut flora and the metabolic factors.
Methods: This will be a multi-center, open labeled trial
Patients: 360 patients with failure to H. pylori eradication for at least two times will be
enrolled Determination of antibiotic resistance of H. pylori:
Agar dilution test will be used to determine the minimum inhibitory concentrations of
levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of
antibiotics.
Treatment regimens and assignment: Eligible patients will be randomized to receive either one
of the treatments (A) Susceptibility testing guided therapy or (B) Empirical therapy
Outcome Measurement:
Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT)
analyses.
Secondary End Point: 1. Eradication rate according to per protocol analysis (PP analysis); 2.
Frequency of adverse effects.