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Clinical Trial
, 17 (6), 793-8

A Rapid, Low-Dose, 13C-urea Tablet for the Detection of Helicobacter Pylori Infection Before and After Treatment

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Clinical Trial

A Rapid, Low-Dose, 13C-urea Tablet for the Detection of Helicobacter Pylori Infection Before and After Treatment

L Gatta et al. Aliment Pharmacol Ther.

Abstract

Background: A new urea breath test (UBT) has been described which uses a tablet formulation of 13C-urea with citric acid and allows breath sampling to be performed as early as 10 min after ingestion of the tablet.

Aim: To assess the diagnostic accuracy of tablet-based 13C-UBTs (50 and 100 mg 13C-urea) before and after Helicobacter pylori eradication treatment, compared with an endoscopy gold standard and a conventional 13C-UBT (75 mg 13C-urea).

Methods: Two hundred dyspeptic patients underwent endoscopy, followed by tablet-based 13C-UBTs (50 and 100 mg 13C-urea) and a conventional 13C-UBT (75 mg 13C-urea). H. pylori-infected patients were prescribed treatment and asked to return 4-6 weeks after the end of therapy for repeat endoscopy and 13C-UBTs.

Results: One hundred and thirteen patients were infected with H. pylori. The sensitivity and specificity of the conventional 13C-UBT were both 100%; the sensitivity and specificity of the 100-mg tablet-based 13C-UBT were 100% and 98.85%, respectively. For the 50-mg tablet-based 13C-UBT, cut-off values of the difference over baseline of between 1.65 and 3.15 provided a sensitivity and specificity of 100%. At follow-up, the sensitivity and specificity of the conventional and 100-mg tablet-based 13C-UBTs were both 100%. For the 50-mg tablet-based 13C-UBT, cut-off values of the difference over baseline of between 1.49 and 1.56 gave a sensitivity and specificity of 100%.

Conclusions: New 10-min 13C-UBTs using tablet formulations of 13C-urea with citric acid are reliable for the assessment of H. pylori status pre- and post-treatment.

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