A novel tablet-based 13C urea breath test for Helicobacter pylori with enhanced performance during acid suppression therapy.
BACKGROUND
The urea breath test (UBT) can still be improved in terms of user-friendliness and accuracy during acid-suppression therapy. This study was designed to evaluate a novel, rapidly disintegrating 13C UBT tablet, which was supplemented with citric acid to facilitate diagnosis of Helicobacter pylori in the hypochlorhydric stomach.


METHODS
The efficacy of a fasting 13C tablet-based UBT (TUBT) was compared with that of a standard 13C UBT (SUBT) during 40 min after dosing, and optimal sampling points were determined. The single-point TUBT was validated against a 'gold standard' (GS) including a TUBT, culture, histology, and a CLO test in 134 dyspeptic patients, and its optimal cut-off point was determined by means of a biometric method. In addition, 20 SUBT-positive patients were randomized to perform either the TUBT or the SUBT after 7 days of omeprazole therapy (20 mg twice daily).


RESULTS
Compared with a SUBT, the TUBT gave a quicker and wider separation between positive and negative results and an earlier optimal sampling point (10 versus 40 min). At 10 min the TUBT correctly classified 40 of 42 GS-positive subjects (sensitivity, 95%) and all of 92 GS-negative patients (specificity, 100%), and the optimal cut-off point was 1.8 delta per mil. Furthermore, when optimal sampling points were used, the TUBT (t = 10 min) proved to be more accurate than the SUBT (t = 40 min) during omeprazole treatment, correctly identifying all of 10 and 3 of 9 H. pylori-infected patients, respectively.


CONCLUSIONS
By supplying 13C urea and citric acid as a rapid-release tablet, it is possible to shorten the duration of the 13C UBT to 10 min, omit the test meal, and still maintain excellent accuracy, even during acid suppression therapy.
Hamlet
A
A
Dept. of Surgery, Sahlgren's University Hospital, Göteborg, Sweden.
Stage
L
L
Lönroth
H
H
Cahlin
C
C
Nyström
C
C
Pettersson
A
A
D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D001944:Breath Tests / Q000379:methods*; D002247:Carbon Isotopes; D004415:Dyspepsia / Q000188:drug therapy / Q000382:microbiology*; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D015203:Reproducibility of Results; D013607:Tablets; D013997:Time Factors; D014508:Urea
D000897:Anti-Ulcer Agents; D002247:Carbon Isotopes; D013607:Tablets; D014508:Urea; D009853:Omeprazole