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Clinical Trials in South Korea / NCT02373280
Recruiting Not applicable

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

NCT02373280 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Bundang Hospital
Phase
Not applicable
Started
2014-08
Last updated
2026-04-24

Condition(s) studied

Helicobacter Infection

Investigational drug(s) / intervention(s)

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)

10 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).

7 day tailored PPI triple therapy (clarithromycin-containing triple therapy): the participants received PPI based triple therapy\[Esomeprazole 40 mg bid 7 days (D1-D7)+amoxicillin 1000mg bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)\]

7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin]: moxifloxacin triple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+Moxifloxacin, 400 mg qd 7 days (D1-D7)+Amoxicillin 1 g bid 7 days (D1-D7)\].

7 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02373280 on ClinicalTrials.gov ↗ ← All trials in South Korea