Double-blind randomized trial of quadruple sequential Helicobacter pylori eradication therapy in asymptomatic infected children in El Paso, Texas

Authors

Carmen A. Prieto-Jimenez, Houston School of Public Health
Victor M. Cardenas, UTHSC
Lori A. Fischbach, University of North Texas
Zuber D. Mulla, Houston School of Public Health
Jose O. Rivera, The University of Texas at El Paso
Delfina C. Dominguez, The University of Texas at El Paso
David Y. Graham, Baylor College of Medicine
Melchor Ortiz, Houston School of Public Health

Publication Date

3-1-2011

Document Type

Article

Abstract

OBJECTIVES: We assessed the efficacy of a novel quadruple sequential 10-day eradication therapy, its compliance, and reported adverse events in a sample of asymptomatically Helicobacter pylori-infected children in El Paso, Texas, as part of a study aiming to assess the influence of this infection on the levels of markers of iron stores. PATIENTS AND METHODS: Using a double-blind randomized trial design, 110 asymptomatic children ages 3 to 11 with H pylori infection were randomly assigned to receive either a 10-day course of sequential eradication therapy plus 6 weeks of iron supplementation, eradication therapy plus placebo, iron supplementation plus placebo, or placebo only. H pylori infection status was assessed ≥45 days after treatment using the urea breath test. Analyses compared the proportion of subjects cured according to assignment to and completion of the sequential eradication therapy. RESULTS: Intent-to-treat and per-protocol analyses indicated that 44.3% and 52.9%, respectively, of the children receiving the novel quadruple sequential therapy had their infection eradicated compared with 12.2% and 15.4% in the arms receiving iron or placebo only, respectively (P < 0.001 in both analyses). Study medications were taken with no or only mild adverse events in most children. CONCLUSIONS: A quadruple sequential regimen eradicated H pylori in only half the asymptomatic children receiving this treatment. There was no difference in the cure rates of those receiving iron supplementation and those receiving placebo. © 2011 Lippincott Williams & Wilkins, Inc.

Publication Title

Journal of Pediatric Gastroenterology and Nutrition

Volume

52

Issue

3

First Page

319

Last Page

325

DOI

10.1097/MPG.0b013e318206870e