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Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection (R+OCA)

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ClinicalTrials.gov Identifier: NCT03124199
Recruitment Status : Completed
First Posted : April 21, 2017
Results First Posted : February 19, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Bacterial Infection Due to Helicobacter Pylori (H. Pylori) Drug: Rifaximin Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rifaximin Associated With Classic Triple Therapy (Inhibitor of Proton Pump, Amoxicillin and Clarithromycin) for the Eradication of Helicobacter Pylori Infection
Study Start Date : February 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Rifaximin
Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice.
 Drug: Rifaximin
Rifaximin 400 mg/8 h added to the standard triple therapy


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With H.Pylori Infection Eradication [ Time Frame: 1 month ]
    Percentage of Participants with H.Pylori Infection Eradication confirmed with urea breath test at least 4 weeks after the end of treatment


Secondary Outcome Measures :
  1. Tolerability of Treatment [ Time Frame: 1 month ]
    Patients with side effects present during treatment and in the 4 weeks after end of treatment

  2. Compliance With Treatment of Patients That Completed the Study [ Time Frame: 1 month ]
    Percentage of patients that has comply with treatment, considered as intake of more than 90% of study drugs in patients who attended the post-treatment visit.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124199


Locations
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Spain
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Sponsors and Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Investigators
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Principal Investigator: Javier Perez, Gisbert Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
More Information
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Publications:

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Responsible Party: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT03124199     History of Changes
Other Study ID Numbers: R+OCA
First Posted: April 21, 2017    Key Record Dates
Results First Posted: February 19, 2018
Last Update Posted: March 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa:
Eradication
Helicobacter pylori
rifaximin
therapy
standard triple therapy
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Rifaximin
 Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents