Helicobacter Infection
Conditions
Keywords
Helicobacter pylori, tailored therapy, eradication
Brief 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.
Detailed 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.
Interventions
DRUG10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole)
In this group, patients will receive the 10 day sequential regimen for eradication of H. pylori. 10 day sequential regimen is like follows; Esomeprazole 40 mg bid 10 days (D1-D10)+amoxicillin 1 g bid 5 days (D1-D5)+clarithromycin 500 mg bid 5 days (D6-D10)+metronidazole 500 mg tid 5 days (D6-D10).
DRUG7 day tailored PPI triple therapy (clarithromycin-containing triple therapy)
the participants received PPI based triple therapy\[Esomeprazole 40 mg bid 7 days (D1-D7)+amoxicillin 1000mg bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)\]
DRUG7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin]
moxifloxacin triple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+Moxifloxacin, 400 mg qd 7 days (D1-D7)+Amoxicillin 1 g bid 7 days (D1-D7)\].
DRUG7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy)
bismuth quadruple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+amoxicillin 1 g bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)\], bismuth quadruple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+Tri potassium dicitrate bismuthate, 300 mg qid 7 days (D1-D7)+Metronidazole, 500 mg tid 7 days (D1-D7)+Tetracycline 500 mg qid 7 days (D1-D7)\] If there was no metronidazole resistance, the treatment was 7 days in duration. If metronidazole resistance was evident, treatment duration was 14 days.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients selected study
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the percentage of participants with successful H. pylori eradication in each groups | 6 weeks after completion of eradication | The efficacy of H. pylori eradication between a 7 days tailored therapy for H. pylori infection based on the results of antimicrobial resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 10 days therapy as first eradication regimen. |
Countries
South Korea
Contacts
CONTACTNayoung Kim, M.D., Ph. D
PRINCIPAL_INVESTIGATORNayoung Kim, M.D., Ph. D
Seoul National University Bundang Hospital
Outcome results
None listed