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OpenTrials
Completed

NCT Number: NCT02547025

Personalized Treatment for Refractory H Pylori Infection

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.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rabeprazole+3 antibiotics

Drug

(rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days.

Other names: rabeprazole 20 mg, amoxicillin 1g, clarithromycin 500mg, metrondazole 250mg, tetracycline 500mg, levofloxacin 500mg

rabeprazole+bismuth+2 antibiotics

Drug

(rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days.

Other names: rabeprazole 20 mg, bismuth subcitrate 120 mg, amoxicillin 1g, clarithromycin 500mg, metrondazole 250mg, tetracycline 500mg, levofloxacin 500mg

rabeprazole+amox+tetr+levo

Drug

(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.

Other names: rabeprazole 20 mg, bismuth subcitrate 120 mg, tetracycline 500mg, levofloxacin 500mg

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

Registry information

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Sep 11, 2015
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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