Actively Recruiting
Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection - A Prospective Randomized, Comparative Study
Led by National Taiwan University Hospital · Updated on 2026-04-15
450
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating different rescue treatment methods for Helicobacter pylori infection, focusing on patients who have previously failed anti-H. pylori therapy. The study aims to compare susceptibility-guided tailored therapy (SG-TT) with guideline-recommended empiric therapy (GR-ET) to understand which approach better eradicates the infection. It also investigates treatment adherence, side effects, and factors influencing treatment success, addressing the challenge of increasing antibiotic resistance worldwide. The study randomly assigns patients to two groups. Group A receives SG-TT, which includes one of five treatment options based on antibiotic susceptibility testing, such as clarithromycin triple therapy, levofloxacin triple therapy, metronidazole triple therapy, high-dose dual therapy, or bismuth quadruple therapy, all administered for 14 days. Group B receives the guideline-recommended empiric therapy, which is bismuth quadruple therapy for 14 days. Treatment selection in Group A follows a priority order based on specific antibiotic resistance profiles. Participants will complete daily questionnaires about symptoms, medication use, and diet during treatment. Follow-up visits will assess adherence and side effects. Four to eight weeks after treatment ends, Helicobacter pylori infection status will be checked using a 13C-urea breath test. Additionally, researchers will analyze the CYP2C19 genotype of each participant. The primary outcome is the eradication rate of the infection over 3.5 years, with secondary outcomes including treatment adherence and side effect frequency.
CONDITIONS
Brief Title
Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 20 years or older
- Diagnosed with Helicobacter pylori-positive chronic gastritis with or without peptic ulcers (duodenal or gastric ulcers)
- Previously failed treatment for Helicobacter pylori infection
- Able to provide written informed consent
You will not qualify if you...
- Pregnant or nursing women
- Serious concomitant illness or any malignant tumor
- History of hypersensitivity to study drugs
- Serious bleeding during ulcer course
- Previous gastric surgery
- Use of bismuth salts, proton pump inhibitors, or antibiotics within the previous month
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 - 14 days
Participants receive one of two 14-day drug treatment regimens to eradicate Helicobacter pylori infection, either susceptibility-guided tailored therapy or guidelines-recommended empiric therapy.
Daily symptom and drug consumption recording during treatment; 1 follow-up visit at the Outpatients Clinic after treatment
Duration - 4 to 8 weeks
Participants are monitored 4 to 8 weeks after treatment to assess Helicobacter pylori infection status and to evaluate adherence and adverse effects.
1 visit for 13C-urea breath test
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
J
Jyh-Chin Yang, M.D.Ph.D.
C
Chien-Chih Tung, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here