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

  • STATUS
    Recruiting
  • End date
    Mar 3, 2023
  • participants needed
    360
  • sponsor
    National Taiwan University Hospital
Updated on 3 February 2021

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.

Details
Condition Helicobacter Pylori Infection, H. Pylori Infection
Treatment ET, SGT
Clinical Study IdentifierNCT04332848
SponsorNational Taiwan University Hospital
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

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
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