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Clarithromycin, Amoxicillin, and Metronidazole Based Regimens to Treat Helicobacter Pylori Infections in Colombia

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ClinicalTrials.gov Identifier: NCT00719420
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : July 21, 2008
Information provided by:

Study Description
Brief Summary:
More than half of the world's population is infected with Helicobacter pylori, a bacterium that colonizes the human stomach. Although most infected subjects live free of symptoms and disease outcomes (except superficial gastritis), only a few develop peptic ulcers or gastric cancer, while some others may develop non-ulcer dyspepsia. Current clinical practice for the management of peptic ulcer disease includes testing for and treating H. pylori, if present. Although there are triple therapies that contain 2 antibiotics plus a bismuth compound, a proton-pump inhibitor, or a H2-receptor antagonist which are effective at eliminating H. pylori in Europe and North America, these treatments are dramatically less effective in developing countries. Our recent meta-analysis showed quadruple therapies containing clarithromycin, amoxicillin, metronidazole and a proton pump inhibitor to be effective in the presence of clarithromycin or metronidazole resistance. However, this regimen has yet to be tested in a developing country. Therefore, in the current randomized clinical trial in Pasto, Colombia, we aim to examine the effectiveness of clarithromycin, amoxicillin, metronidazole with and without a proton pump inhibitor compared to the Food and Drug Administration approved 10-day regimen containing clarithromycin, amoxicillin and omeprazole. Since antibiotic therapy is most effective within a specific gastric pH range, and since mutifocal atrophy results in damage and loss of the acid producing parietal cells, we will test the efficacy of our modified therapy stratified by diagnosis of multifocal atrophic gastritis.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Clarithromycin, Metronidazole, Amoxicillin (+Omeprazole) Drug: Clarithromycin, Amoxicillin, Omeprazole Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial to Examine the Efficacy of a Clarithromycin-, Amoxicillin-, and Metronidazole-Based Regimen to Eradicate Helicobacter Pylori Infections in Pasto, Colombia
Study Start Date : April 2006
Primary Completion Date : February 2007
Study Completion Date : February 2007

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Clarithromycin 500 mg bid, metronidazole 500 mg tid, and amoxicillin 500mg tid for 14 days (with or without omeprazole 20 mg bid)
Drug: Clarithromycin, Metronidazole, Amoxicillin (+Omeprazole)
Clarithromycin 500 mg bid, metronidazole 500 mg tid, and amoxicillin 500mg tid with or without omeprazole 20 mg bid for 14 days
Other Name: Biaxin, Flagyl, Amoxil, Prilosec
Active Comparator: 2
Clarithromycin 500 mg bid, amoxicillin 1 g bid, and omeprazole 20 mg bid for 10 days
Drug: Clarithromycin, Amoxicillin, Omeprazole
Clarithromycin 500 mg bid, amoxicillin 1 g bid, and omeprazole 20 mg bid for 10 days
Other Name: Biaxin, Amoxil, Prilosec

Outcome Measures

Primary Outcome Measures :
  1. Helicobacter pylori eradication determined by 13C-urea breath test. [ Time Frame: 4-6 weeks following the completion of treatment ]

Secondary Outcome Measures :
  1. Dyspeptic symptom resolution ascertained by self-report. [ Time Frame: 4-6 weeks following the completion of treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   29 Years to 77 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Aged 29-77 years; have lived in Pasto, Colombia for at least 5 years and plan to remain in Pasto for ≥5 more years;
  • Currently have Helicobacter pylori infection;
  • Willing to refrain from alcohol consumption for 2 weeks;
  • Have never taken a therapy to eradicate Helicobacter pylori;
  • Have not taken antibiotics, bismuth compounds, proton-pump inhibitors, H2-receptor antagonists, or antacids within 30 days of the trial;
  • Are not pregnant, and have little or no risk of pregnancy.

Exclusion Criteria:

  • History of kidney, liver, heart, or mental disease;
  • Frequent alcohol consumption;
  • Allergic to clarithromycin, amoxicillin, penicillin, omeprazole or metronidazole;
  • Currently taking drugs which may interact with any of the trial medications.
Contacts and Locations

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): NCT00719420

Universidad del Valle
Cali, Colombia
Sponsors and Collaborators
University of North Texas Health Science Center
Universidad del Valle, Colombia
Vanderbilt University
Principal Investigator: Lori A Fischbach, PhD, MPH University of North Texas Health Science Center
Study Chair: Pelayo Correa, MD Vanderbilt University
Study Director: Luis E Bravo, MD Universidad del Valle
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Lori A. Fischbach, University of North Texas Health Science Center
ClinicalTrials.gov Identifier: NCT00719420     History of Changes
Other Study ID Numbers: 06-02-24-2
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: July 21, 2008
Last Verified: July 2008

Keywords provided by University of North Texas Health Science Center:
Randomized clinical trial
Helicobacter pylori
proton pump inhibitor

Additional relevant MeSH terms:
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors