Validation of the 13C-urea breath test for the diagnosis of Helicobacter pylori infection in children: a multicenter study.
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.
Bazzoli
F
F
Dipartimento di Medicina Interna e Gastroenterologia, Università di Bologna, Italy.
Cecchini
L
L
Corvaglia
L
L
Dall'Antonia
M
M
De Giacomo
C
C
Fossi
S
S
Casali
L G
LG
Gullini
S
S
Lazzari
R
R
Leggeri
G
G
Lerro
P
P
Valdambrini
V
V
Mandrioli
G
G
Marani
M
M
Martelli
P
P
Miano
A
A
Nicolini
G
G
Oderda
G
G
Pazzi
P
P
Pozzato
P
P
Ricciardiello
L
L
Roda
E
E
Simoni
P
P
Sottili
S
S
Zagari
R M
RM
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*
D014508:Urea