7-day tailored treatment to eradicate H. pylori infection
A Prospective, Single-center, Open-label, Clinical Trial to Compare the 10-day Sequential Therapy and 7-day Culture Based Tailored Therapy for the Eradication of Helicobacter Pylori
This will test whether a 7-day treatment chosen using H. pylori culture and antibiotic susceptibility works better than the usual 10-day sequential regimen for adults with H. pylori infection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT02373280 on ClinicalTrials.gov |
What this trial studies
Because antibiotic resistance to H. pylori has been rising in Korea, investigators compared a 7-day regimen chosen from culture and minimal inhibitory concentration (MIC) results with a standard 10-day sequential regimen. Patients with confirmed H. pylori (by rapid urease test, histology, or urea breath test) received either the tailored 7-day therapy (PPI-based triple, bismuth quadruple, or moxifloxacin-containing triple depending on susceptibility) or 10-day sequential therapy. The primary outcome was eradication success rate; investigators also measured the prevalence of antibiotic resistance in the tailored group. The trial was conducted at a single center using microbiology-guided selection to individualize therapy.
Who should consider this trial
Good fit: Adults (age ≥18) in Korea with confirmed H. pylori infection who have not previously received eradication therapy and who are not pregnant or lactating and meet safety labs are eligible.
Not a fit: Patients with prior H. pylori eradication, recent antibiotic or bismuth or PPI use within the exclusion windows, significant liver or kidney disease, pregnancy/lactation, or known allergies to study drugs are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, tailored 7-day therapy could raise eradication rates and reduce unnecessary use of ineffective antibiotics.
How similar studies have performed: Susceptibility-guided H. pylori therapy has improved eradication rates in multiple settings, but results vary and data are more limited in Korean populations facing high resistance.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seongnam-si, Gyeonggi-do
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Principal investigator: Nayoung Kim, M.D., Ph. D — Seoul National University Bundang Hospital
- Study coordinator: Nayoung Kim, M.D., Ph. D
- Email: nayoungkim49@empas.com
- Phone: 82-31-787-7008
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.