Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
Background: A progressive decrease in Helicobacter pylori eradication rates has been
described over the years, so new combinations of antibiotics for treatment are needed.
Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple
therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori.
Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty
consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and
naive to eradication treatment. A full blood test was performed in the first 5 patients
included to evaluate the safety of the treatment. H. pylori eradication was confirmed with
urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8
h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.
Phase:
Phase 3
Details
Lead Sponsor:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa