Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection
Condition: Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Intervention: Rifaximin
Intervention description: Rifaximin 400 mg/8 h added to the standard triple therapy
Intervention MeSH terms: Rifaximin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Eradication; Helicobacter pylori; rifaximin; therapy; standard triple therapy

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age greater than or equal to 18 years.

          2. 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.

          3. Having been previously prescribed by routine clinical practice the standard triple
             therapy as eradication treatment:

               -  Proton Pump Inhibitor. Omeprazole 40 mg (or equivalent) every 12 hours. Treatment
                  duration: 10 days.

               -  Clarithromycin. Dose: 500 mg every 12 hours. Treatment duration: 10 days.

               -  Amoxicillin. Dose: 1000 mg every 12 hours. Treatment duration: 10 days.

          4. Not having yet begun taking the eradication therapy.

          5. Written informed consent from the patient.

          6. 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.

          7. 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:

          1. 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).

          2. Allergy to any of the antibiotic in the treatment.

          3. Taking antibiotics or bismuth salts since performing the breath test.

          4. Previous gastric surgery.

          5. Presence of severe pulmonary, hepatic, renal, endocrine, metabolic, hematologic or
             tumor disease.

          6. Very advanced chronic disease or other conditions that prevent attending to controls
             and follow ups.

          7. Previous history of alcohol or drugs abuse.

          8. Patients who are pregnant or lactating.