title: Double-blind randomized trial of quadruple sequential Helicobacter pylori eradication therapy in asymptomatic infected children in El Paso, Texas.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Department of Pediatrics, El Paso, Texas, USA.
authors.forename: Carmen A
authors.initials: CA
authors.lastname: Prieto-Jimenez
authors.forename: Victor M
authors.initials: VM
authors.lastname: Cardenas
authors.forename: Lori A
authors.initials: LA
authors.lastname: Fischbach
authors.forename: Zuber D
authors.initials: ZD
authors.lastname: Mulla
authors.forename: Jose O
authors.initials: JO
authors.lastname: Rivera
authors.forename: Delfina C
authors.initials: DC
authors.lastname: Dominguez
authors.forename: David Y
authors.initials: DY
authors.lastname: Graham
authors.forename: Melchor
authors.initials: M
authors.lastname: Ortiz
mesh_terms: D000900:Anti-Bacterial Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D019587:Dietary Supplements; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D057194:Intention to Treat Analysis; D019266:Iron, Dietary / Q000494:pharmacology; D008297:Male; D013781:Texas; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D019266:Iron, Dietary