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

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.

Conditions

• Helicobacter Pylori Infection

Interventions

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

DRUG

Clarithromycin, Amoxicillin, Omeprazole

Clarithromycin 500 mg bid, amoxicillin 1 g bid, and omeprazole 20 mg bid for 10 days

Sponsors & Collaborators

• Universidad del Valle, Colombia

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• University of North Texas Health Science Center

  lead OTHER

Principal Investigators

• Lori A Fischbach, PhD, MPH · University of North Texas Health Science Center

• Pelayo Correa, MD · Vanderbilt University

• Luis E Bravo, MD · Universidad del Valle

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

29 Years

Max Age

77 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-04-30

Primary Completion

2007-02-28

Completion

2007-02-28

Countries

• Colombia

Study Locations