The Efficacy of the 7 Days Tailored Therapy as the 1st Eradication of H. Pylori Infection

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    600
  • sponsor
    Seoul National University Bundang Hospital
Updated on 31 March 2021

Summary

To compare the eradication success rate between 10-days sequential therapy and 7-days tailored therapy based on H. pylori culture and antimicrobial susceptibility testing.

Description

As increasing antimicrobial resistance in Korea, the effectiveness of empirical Helicobacter pylori (H. pylori) therapies have been declined. Recently, 10-day sequential therapy was not sufficient to overcome tough situation for H. pylori eradication.

Thus, in this study, the investigators evaluated the efficacy of H. pylori eradication between a 7 days tailored therapy (7 day PPI based triple therapy, bismuth quadruple therapy or moxifloxacin contained triple therapy) for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 10 day sequential therapy for the first eradication of H. pylori infection, and the investigators analyzed the prevalence of the antibiotic resistance in the tailored therapy group.

Details
Condition Helicobacter Infections
Treatment 10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole), 7 day tailored PPI triple therapy (clarithromycin-containing triple therapy), 7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin], 7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy)
Clinical Study IdentifierNCT02373280
SponsorSeoul National University Bundang Hospital
Last Modified on31 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

The patients who proved H. pylori infection following three methods
positive rapid urease test (CLOtest)
histologic evidence of H. pylori by modified Giemsa staining
positive Urea breath test
Male and female Korean Adult (Aged 18 years)

Exclusion Criteria

Patients who received eradication therapy for H. pylori infection, previously
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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