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Recruiting Not applicable NCT02373280

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

No applicable phase (e.g. observational)
Conditions: Helicobacter Infection

Sponsor: Seoul National University Bundang Hospital

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * The patients who proved H. pylori infection following three methods 1. positive rapid urease test (CLOtest) 2. histologic evidence of H. pylori by modified Giemsa staining 3. 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
Interventions
10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole)
DRUG
7 day tailored PPI triple therapy (clarithromycin-containing triple therapy)
DRUG
7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin]
DRUG
7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy)
DRUG
Locations 1
South Korea (1)
Seoul National University Bundang Hospital
Seongnam-si , Gyeonggi-do
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
85 Years
Healthy volunteers
No
Start date
01.08.2014
Completion date
01.12.2027
Registry ID
NCT02373280
Source
clinicaltrials.gov
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