Comparing treatment durations for Helicobacter Pylori infection

Helicobacter Pylori Eradication According to DPO-PCR Methods: Duration of Triple Therapy and Bismuth Quadruple According to Clarithromycin Resistance Patterns (K-CREATE Study)

This study is testing whether a 7-day or a 14-day treatment for Helicobacter Pylori infection works better for people based on their antibiotic resistance.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1230 (estimated)
• Ages: 20 Years to 75 Years
• Sex: All
• Sponsor: Incheon St.Mary's Hospital (Academic / other)
• Locations: 1 site (Incheon)
• Trial ID: NCT04147065 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of different treatment durations for Helicobacter Pylori infection using dual priming oligonucleotide-polymerase chain reaction (DPO-PCR) to tailor therapy based on antibiotic resistance. Patients will be randomized to receive either empirical or tailored therapy, with variations in treatment duration and type based on clarithromycin susceptibility. The study aims to compare the eradication rates and adverse events associated with 7-day versus 14-day treatment regimens in both clarithromycin-sensitive and resistant strains. Conducted across 20 university hospitals, this multi-center trial seeks to optimize H. Pylori eradication strategies.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with Helicobacter Pylori infection who have undergone an upper endoscopic examination within the last three months.

Not a fit: Patients with a history of H. pylori eradication or those who have undergone stomach resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with Helicobacter Pylori infection.

How similar studies have performed: Previous studies have shown that tailoring treatment based on antibiotic resistance can improve eradication rates, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* Participants who had upper endoscopic examination within 3 months and diagnosed by Helicobacter pylori infection either by rapid urease test, urea breath test, or histopathologic examination.

Participants who voluntarily want to participate in this study.

Exclusion Criteria:

History of H. pylori eradication History of stomach resection. Allergy or adverse events related to eradication medication. Administration of proton-pump inhibitor within 2 weeks or Histamine 2 receptor blocker within 1 week.

Administration of these drugs within a week or who need continuous administration of these drugs; aspirin (except low-dose aspirin for primary prophylaxis of cardiovascular disease), intravenous or oral NSAID, anticholinergics, prostaglandin analogs, pro-motility drugs, sucralfate Administration of antibiotics within 4 weeks. Pregnant, breast feeding participant or who do not have a will to avoid pregnancy during clinical trial Administrating one of these drugs (Lovastatin, Simvastatin, Atorvastatin, Indinavir, Ritonavir, Cyclosporin, Terfenadine, Cisapride, Pimozide, Astemizole, HIV protease inhibitors (Atazanavir, Nelfinavir), Ergotamine, Dihydroergotamine, Mizolastine, Bepridil, Ticagrelor) Infectious mononucleosis Central nervous system infection Hematologic disease Galactose intolerance Lactase deficiency Glucose-galactose malabsorption Torsades de pointes.

Where this trial is running

Incheon

• Incheon St. Mary's Hospital — Incheon, South Korea (Recruiting)

Study contacts

• Principal investigator: Byung-Wook Kim, MD, PhD — Incheon St.Mary's Hospital
• Study coordinator: Joon S Kim, MD, PhD

Conditions Helicobacter Pylori Infection; Helicobacter; Empirical; Tailored