title: Validation of the 13C-urea breath test for the diagnosis of Helicobacter pylori infection in children: a multicenter study.
abstract: OBJECTIVE
  The 13C-urea breath test (13C-UBT) is a safe, noninvasive, and accurate test for the detection of Helicobacter pylori (H. pylori) infection in adults. The aim of this study was to evaluate sensitivity and specificity of 13C-UBT in children using different types of test meal, doses of 13C-urea and breath sampling intervals. As yet, a validated, standardized 13C-UBT protocol for children has not been formulated.
  
  
  METHODS
  13C-UBT was performed in 115 children and repeated within 3 days, modifying the test meal or the dose of 13C-urea. H. pylori status was assessed by histology and rapid urease test. 13C-UBT was performed using 100 mg or 50 mg of 13C-urea and a fatty test meal (100 FA; 50 FA), 50 mg of 13C-urea, and a carbohydrate test meal (50 CA). Breath samples were collected every 10 min for 60 min.
  
  
  RESULTS
  The 13C-UBT in children was highly sensitive and specific with all three protocols used. The best combination of sensitivity (97.92%) and specificity (97.96%) was obtained with Protocol 50 FA at 30 min with a cut-off of 3.5 per mil.
  
  
  CONCLUSIONS
  The 13C-UBT is an accurate test for the detection of H. pylori infection also in children. Administration of 50 mg of 13C-urea, a fatty test meal, and breath sampling at 30 min appears to be the most convenient protocol.
authors.affiliation: Dipartimento di Medicina Interna e Gastroenterologia, Università di Bologna, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Bazzoli
authors.forename: L
authors.initials: L
authors.lastname: Cecchini
authors.forename: L
authors.initials: L
authors.lastname: Corvaglia
authors.forename: M
authors.initials: M
authors.lastname: Dall'Antonia
authors.forename: C
authors.initials: C
authors.lastname: De Giacomo
authors.forename: S
authors.initials: S
authors.lastname: Fossi
authors.forename: L G
authors.initials: LG
authors.lastname: Casali
authors.forename: S
authors.initials: S
authors.lastname: Gullini
authors.forename: R
authors.initials: R
authors.lastname: Lazzari
authors.forename: G
authors.initials: G
authors.lastname: Leggeri
authors.forename: P
authors.initials: P
authors.lastname: Lerro
authors.forename: V
authors.initials: V
authors.lastname: Valdambrini
authors.forename: G
authors.initials: G
authors.lastname: Mandrioli
authors.forename: M
authors.initials: M
authors.lastname: Marani
authors.forename: P
authors.initials: P
authors.lastname: Martelli
authors.forename: A
authors.initials: A
authors.lastname: Miano
authors.forename: G
authors.initials: G
authors.lastname: Nicolini
authors.forename: G
authors.initials: G
authors.lastname: Oderda
authors.forename: P
authors.initials: P
authors.lastname: Pazzi
authors.forename: P
authors.initials: P
authors.lastname: Pozzato
authors.forename: L
authors.initials: L
authors.lastname: Ricciardiello
authors.forename: E
authors.initials: E
authors.lastname: Roda
authors.forename: P
authors.initials: P
authors.lastname: Simoni
authors.forename: S
authors.initials: S
authors.lastname: Sottili
authors.forename: R M
authors.initials: RM
authors.lastname: Zagari
mesh_terms: D000293:Adolescent; D000328:Adult; D001830:Body Surface Area; D001944:Breath Tests; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D005753:Gastric Mucosa / Q000473:pathology; D005756:Gastritis / Q000175:diagnosis* / Q000473:pathology; D005773:Gastroscopy; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000473:pathology; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D012015:Reference Standards; D012680:Sensitivity and Specificity; D014508:Urea / Q000032:analysis*
chemical_list: D014508:Urea