Double‐blind Randomized Trial of Quadruple Sequential Helicobacter pylori Eradication Therapy in Asymptomatic Infected Children in El Paso, Texas

Abstract

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. 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. 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. 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.