Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.

  • STATUS
    Recruiting
  • participants needed
    362
  • sponsor
    University of Bari
Updated on 29 May 2022

Summary

The aim of our study will be to assess in an open-label, multicenter, randomized controlled trial whether a tailored therapy guided by a non-invasive antibiotic susceptibility test on stool samples achieves higher Helicobacter eradication rates than an empiric antibiotic regimen. For this purpose, consecutive patients with dyspeptic symptoms, diagnosis of Helicobacter pylori infection and nave to eradicating treatments will be allocated to either of the two intervention arms.

Description

Study design:

Eligible subjects will be defined by the positivity to at least 2 out of 4 tests for Helicobacter pylori infection diagnosis (i.e. histology, rapid urease test, urea breath test and serology). Stool samples and gastric biopsy specimens of eligible patients will be analyzed at enrollment, using real time-polymerase chain reaction (RT-PCR) to detect bacterial DNA mutations conferring resistance to amoxicillin, clarithromycin, tetracycline, metronidazole, and levofloxacin. Participants allocated to the tailored intervention arm will receive an antibiotic combination therapy according to the result of stool sample molecular analysis. Participants allocated to the empiric intervention arm will be treated by either a quadruple concomitant or bismuth-containing regimen, according to the 2017 European Helicobacter pylori management guidelines. In all participants, infection eradication will be evaluated 30 days after treatment end, using urea breath test. We will also assess the diagnostic accuracy of the RT-PCR on fecal samples in detecting bacterial antibiotic resistances, using the RT-PCR on gastric biopsy specimens as the reference standard.

Details
Condition Helicobacter Pylori Infection, H. Pylori Infection, Antibiotic Resistant Infection, Antibiotic Resistant Strain
Treatment metronidazole, Levofloxacin 500mg, Clarithromycin 500mg, Pantoprazole 40mg, Amoxicillin 1000 MG, Amoxicillin 1000 MG, Tetracycline 125 MG, Bismuth Subcitrate, Rifabutin 150 MG, Rifabutin 150 MG
Clinical Study IdentifierNCT04107194
SponsorUniversity of Bari
Last Modified on29 May 2022

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