Validation of the C-13-urea breath test for the diagnosis of Helicobacter pylori infection in children: A multicenter study

OBJECTIVE: The C-13-urea breath test (C-13-UBT) is a safe, noninvasive, and accurate test for the detection of Helicobacter pylori (H. pylori) infecti on in adults. The aim of this study was to evaluate sensitivity and specifi city of C-13-UBT in children using different types of test meal, doses of C -13-urea and breath sampling intervals. As yet, a validated, standardized C -13-UBT protocol for children has not been formulated. METHODS: C-13-UBT was performed in 115 children and repeated within 3 days, modifying the test meal or the dose of C-13-urea. H. pylori status was ass essed by histology and rapid urease test. C-13-UBT was performed using 100 mg or 50 mg of C-13-urea and a fatty test meal (100 FA; 50 FA), 50 mg of C- 13-urea, and a carbohydrate test meal (50 CA). Breath samples were collecte d every 10 min for 60 min. RESULTS: The C-13-UBT in children was highly sensitive and specific with al l three protocols used. The best combination of sensitivity (97.92%) and sp ecificity (97.96%) was obtained with Protocol 50 FA at 30 min with a cut-of f of 3.5 per mil. CONCLUSIONS: The C-13-UBT is an accurate test for the detection of H. pylor i infection also in children. Administration of 50 mg of C-13-urea, a fatty test meal, and breath sampling at 30 min appears to be the most convenient protocol. (Am J Gastroenterol 2000;95:646-650. (C) 2000 by Am. Coll. of Ga stroenterology).