Susceptibility Testing Guided Versus Empirical Therapy for Refractory H. Pylori Infection

Recruiting now · Phase 4

Conditions studied: Helicobacter Pylori Infection

In brief

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.

Key facts

Study ID
NCT04332848
Run by
National Taiwan University Hospital
People needed
360
Starts
2020-07-28
Expected to finish
2026-12-01
Last updated by the study team
2025-08-29

Who can join

Age: 20 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Where it is running

Full record on ClinicalTrials.gov

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