The Efficacy of the 7 Days Tailored Therapy as 2nd Rescue Therapy for Eradication of H. Pylori Infection

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    370
  • sponsor
    Seoul National University Bundang Hospital
Updated on 31 March 2021

Summary

As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter pylori (H. pylori) therapies has been declined coincidentally.

In this study, the investigators evaluated the efficacy of H. pylori eradication between a 7 days personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 14 days bismuth contained quadruple 2nd rescue regimens, and the investigators analyzed the prevalence of the antibiotic resistance after 1st eradication of H. pylori in the tailored therapy group.

Description

The patients who had shown the evidence of persistent H. pylori infection after the 1st eradication were enrolled for this study.

After giving the informed consent about the method and efficacy (ITT and PP analysis) of the 14 days bismuth quadruple 2nd rescue therapy and the 7 days tailored therapy for H. pylori infection based on culture and MIC, the patients were randomly classified into the two regimen group under the patient's agreement and underwent 2nd eradication [14 days bismuth-based quadruple therapy (Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d.), or 7 days tailored therapy based on H. pylori culture and MIC (select the 2nd rescue regimen between 7 days of bismuth-based quadruple therapy or 7 days moxifloxacin-containing triple therapy (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.) according to antibiotics susceptibility.

This study was designed to evaluate the success of eradication for enrolled participants by methods of an open labelled randomized prospectively.

Details
Condition Helicobacter Infections
Treatment moxifloxacin, Amoxicillin, metronidazole, Tetracycline, H. pylori culture and antimicrobial susceptibility testing, 14 days empirical bismuth quadruple therapy (Proton pump inhibitor), tripotassium dicitrate bismuthate, 7 days tailored therapy Proton Pump Inhibitor
Clinical Study IdentifierNCT02359331
SponsorSeoul National University Bundang Hospital
Last Modified on31 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

The patients who proved a failure of 1st eradication of H. pylori with Proton pump inhibitor based triple therapy (PPI bid + amoxacillin 1g b.i.d + Clarithromycin 500 mg b.i.d) or sequential therapy (initial 5-day therapy with a combination of PPI b.i.d and amoxicillin 1g b.i.d, followed by 5 days of PPI b.i.d., clarithromycin 500mg b.i.d., and metronidazole 500mg t.i.d) following three methods
positive rapid urease test (CLOtest)
histologic evidence of H. pylori by modified Giemsa staining
positive 13C-Urea breath test
Male and female Korean Adult (Aged 18 years)

Exclusion Criteria

Patients who received two or more eradication therapy for H. pylori infection
H. pylori eradication failure because of poor compliance
the administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
Advanced gastric cancer or other malignancy
Abnormal liver function or liver cirrhosis
Abnormal renal function or chronic kidney disease
Other severe concurrent diseases
Previous allergic reactions to the study drugs
Pregnant or lactating women
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