Overview

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

Status:
Recruiting

Trial end date:
2023-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Taiwan University Hospital

Criteria

Inclusion criteria

- Adult (equal or greater than 20 years old) patients who failed from at least two
eradication therapies for H. pylori infection will be enrolled.