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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 29, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Mar 2023 to Dec 2025 Completion date: Mar 2023 to Dec 2026 · Start date: Jul 24, 2020 to Jul 28, 2020v3 Show 2 more changesShow less
    • Completion date: Mar 2023 to Dec 2026
    • Start date: Jul 24, 2020 to Jul 28, 2020
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 2020 to Jul 24, 2020 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Apr 2020 to Jul 24, 2020
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04332848
Lead Sponsor National Taiwan University Hospital
Conditions Helicobacter Pylori Infection
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov