Actively Recruiting
Comparing 10-day Sequential Therapy and 7-day Culture-Based Tailored Therapy for Helicobacter pylori Eradication
Led by Seoul National University Bundang Hospital · Updated on 2026-04-24
600
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the success rates of two treatments for Helicobacter pylori infection: a 10-day sequential therapy and a 7-day tailored therapy based on bacterial culture and antibiotic sensitivity testing. This study addresses the challenge of rising antibiotic resistance in Korea, which has reduced the effectiveness of standard empirical treatments for H. pylori. Participants will receive either the 10-day sequential regimen consisting of esomeprazole, amoxicillin, clarithromycin, and metronidazole, or a 7-day tailored therapy guided by antibiotic susceptibility results. The tailored therapy may include a proton pump inhibitor (PPI) triple therapy, moxifloxacin triple therapy, or bismuth quadruple therapy. The bismuth quadruple therapy duration may be extended to 14 days if resistance to metronidazole is detected. During the study, participants will be monitored for successful eradication of H. pylori six weeks after treatment completion. The study involves endoscopic biopsy for culture and susceptibility testing in the tailored therapy group. Researchers will evaluate antibiotic resistance prevalence and the eradication rates for each treatment. Participation lasts through treatment and follow-up assessments to measure treatment outcomes.
CONDITIONS
Brief Title
The Efficacy of the 7 Days Tailored Therapy as the 1st Eradication of H. Pylori Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with Helicobacter pylori infection by rapid urease test, biopsy staining, or urea breath test
- Male and female Korean adults
You will not qualify if you...
- Previous treatment for H. pylori infection
- Prior failure of H. pylori eradication due to poor compliance
- Use of antibiotics or bismuth salts within 4 weeks before study
- Use of proton pump inhibitors within 2 weeks before study
- Advanced gastric cancer or other malignancies
- Abnormal liver function or liver cirrhosis
- Abnormal kidney function or chronic kidney disease
- Other severe concurrent illnesses
- Known allergies to study drugs
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 to 14 days
Participants diagnosed with H. pylori infection receive one of the following antibiotic regimens based on group assignment and antibiotic susceptibility testing: a 10-day sequential therapy, a 7-day tailored PPI triple therapy, a 7-day moxifloxacin-based triple therapy, or a 7 or 14-day tailored bismuth quadruple therapy. Treatment duration varies by regimen and resistance profile.
1 treatment period with medication taken daily
Duration - 6 weeks after treatment
Participants return approximately 6 weeks after completing treatment to assess the success of H. pylori eradication.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707
Actively Recruiting
Research Team
N
Nayoung Kim, M.D., Ph. D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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