Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infec… (NCT03124199) | Clinical Trial Compass
CompletedPhase 3
Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection
Spain40 participantsStarted 2014-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age greater than or equal to 18 years.
✓. Patients with dyspeptic symptoms, ie pain or discomfort (including abdominal bloating, early satiety and bloating) centered on the upper abdomen, persistent or recurrent, with proven H. pylori infection (through testing breath or gastric biopsy based methods, if it has been done) with a validity period of one year.
✓. Having been previously prescribed by routine clinical practice the standard triple therapy as eradication treatment:
✓. Not having yet begun taking the eradication therapy.
✓. Written informed consent from the patient.
✓. The first five patients included in the study, should had cited from the outpatient and prior to his arrival in consultation, a routine analysis in the month after the completion of the eradication therapy.
✓. If the patient is a woman of childbearing age, she will be asked to commit to not get pregnant or to use an adequate contraception method.
Exclusion criteria
✕. Previous eradication treatment for H. pylori (these patients are often carriers of antibiotic resistant strains and have a much lower response than those that had never received treatment).
What they're measuring
1
Percentage of Participants With H.Pylori Infection Eradication