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• W2330895783 abstract "The urea breath test using stable isotope carbon (13C) has been proven to be a useful, non-invasive method for diagnosing Helicobacter pylori (H. pylori) infection. The 13C-urea breath test drug C-13 UBT is currently available as a granule formulation (UBIT®) that is dissolved in tap water immediately before ingestion. However, there is a drawback with this formulation in that patients are required to rinse their mouth several times with water immediately after ingestion of UBIT® in order to avoid the false-positive test result associated with the urease activity of indigenous buccal flora. In order to eliminate the need for this troublesome mouth rinsing, a film-coated tablet formulation of C-13 UBT is currently under development. Theoretically, the use of C-13 UBT tablets should make mouth rinsing unnecessary ;however, this hypothesis has not yet been proven. Therefore, in the present study, the influence of mouth rinsing on the 13CO2 concentration in expired breath was fully investigated in 20 healthy male adults.Prior to enrollment in the study the subjects underwent the urea breath test using UBIT®. They were then divided into 2 groups of 10 patients each (7 H. pylori-negative subjects and 3 H. pylori-positive subjects) and underwent urea breath tests using C-13 UBT tablets in a cross-over manner with or without mouth rinsing immediately after ingestion at a 1-week interval. Breath samples were collected immediately before and 5, 10, 15, 20, and 30 min after ingestion, and the 13CO2/12CO2 value (‰) was calculated. The change (Δ13C, ‰) in the 13CO2/12CO2 value (‰) from the pre-ingestion value was used as an index for assessment of positive (≥2.5‰) or negative (<2.5‰) for H. pylori infection.For all 14 breath tests in H. pylori-negative subjects, the Δ13C value did not exceed the cut-off value of 2.5 ‰ at any measurement point, with maximal values of 1.07‰ without mouth rinsing and 1.26 ‰ with mouth rinsing. In the H.pylori-positive subjects, the Δ13C value at 15 min following ingestion and afterwards was 5.25 ‰ or higher in all 6 breath tests.In conclusion, the results suggest that the urea breath test employing C-13 UBT tablets is capable of producing an accurate diagnosis of H. pylori infection without mouth rinsing following ingestion using breath samples collected 20 min after ingestion with a cut-off value of 2.5 ‰." @default.
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• W2330895783 date "2002-01-01" @default.
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• W2330895783 title "Clinical Pharmacology Study of C-13 UBT Tablet for the in vivo Diagonosis of Helicobacter pylori Infection." @default.
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• W2330895783 doi "https://doi.org/10.3999/jscpt.33.3_81" @default.
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