Personalized Treatment for Refractory H Pylori Infection

Overview

In this study, the investigators develop a personalized treatment according to culture-guided antibiotics plus high-dose proton-pump inhibitor and bismuth to treat refractory H pylori infection.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2021

Detailed Description

They are categorized into three groups: (1) patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics), (2) patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics), and (3) patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.

Interventions

  • Drug: rabeprazole+3 antibiotics
    • (rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days.
  • Drug: rabeprazole+bismuth+2 antibiotics
    • (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days.
  • Drug: rabeprazole+amox+tetr+levo
    • (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.

Arms, Groups and Cohorts

  • Experimental: rabeprazole+3 antibiotics
    • patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days
  • Experimental: rabeprazole+bismuth+2 antibiotics
    • patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days
  • Active Comparator: rabeprazole+amox+tetr+levo
    • patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants in Which H. Pylori Was Eradicated
    • Time Frame: eight weeks after the end of anti-H pylori therapy
    • To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.

Participating in This Clinical Trial

Inclusion Criteria

H pylori-infected adult patients with at least two previous failed eradication attempts will be enrolled in this study after giving informed consent.

  • positive results of both rapid urease test and histology, – a positive result of Urea breath test, – or a positive result of culture Exclusion Criteria:

  • ingestion of antibiotics, bismuth, or proton-pump inhibitor within the prior 4 weeks, – patients with allergic history to the medications used, – patients with previous gastric surgery, – the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia), – pregnant women.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kaohsiung Veterans General Hospital.
  • Collaborator
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ping-I (William) Hsu, M.D., Professor – Kaohsiung Veterans General Hospital.
  • Overall Official(s)
    • Ping-I Hsu, Bachelor, Study Chair, Kaohsiung Veterans General Hospital.

References

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