OBJECTIVE: The U.S. standard 13C-urea breath test (13C-UBT) has proven to be extremely reliable but entails several complicated performance requirements and a test period of approximately 1 h. The aim of this study was to compare the standard 13C-UBT with a simplified version embodying modifications of test meal, duration of fasting, amount of 13C-urea, method of breath collection, and duration of test. METHODS: This was a randomized, three-way, crossover study of the standard U.S. 13C-UBT, which contains 125 mg of 13C-urea and a pudding test meal. The final breath sample is taken 30 min after urea ingestion. This test was compared with a formulation containing 75 mg of 13C-urea, a 2.5-g citric acid test meal (UBT-Lite), and a final breath sample taken by direct exhalation into tubes 15 min after urea ingestion. We also compared the effect of prior meals versus fasting on the test outcome with the UBT-Lite. RESULTS:A total of 259 subjects were enrolled in the trial, and 249 completed all three urea breath tests. There was excellent agreement between the three versions of the UBT with >98% of subjects having concordant results. Using predetermined criteria, there was substantial equivalence between the tests. Neither solid and/or liquid food up to 1 h before performing the UBT-Lite affected outcome. CONCLUSION: The UBT-Lite formulation of the 13C-UBT proved to be an improved version of the U.S. standard 13C-UBT offering less expensive ingredients, shorter test duration, and a simplified breath test collection method, without sacrificing accuracy.
RCT Entities:
OBJECTIVE: The U.S. standard 13C-urea breath test (13C-UBT) has proven to be extremely reliable but entails several complicated performance requirements and a test period of approximately 1 h. The aim of this study was to compare the standard 13C-UBT with a simplified version embodying modifications of test meal, duration of fasting, amount of 13C-urea, method of breath collection, and duration of test. METHODS: This was a randomized, three-way, crossover study of the standard U.S. 13C-UBT, which contains 125 mg of 13C-urea and a pudding test meal. The final breath sample is taken 30 min after urea ingestion. This test was compared with a formulation containing 75 mg of 13C-urea, a 2.5-g citric acid test meal (UBT-Lite), and a final breath sample taken by direct exhalation into tubes 15 min after urea ingestion. We also compared the effect of prior meals versus fasting on the test outcome with the UBT-Lite. RESULTS: A total of 259 subjects were enrolled in the trial, and 249 completed all three urea breath tests. There was excellent agreement between the three versions of the UBT with >98% of subjects having concordant results. Using predetermined criteria, there was substantial equivalence between the tests. Neither solid and/or liquid food up to 1 h before performing the UBT-Lite affected outcome. CONCLUSION: The UBT-Lite formulation of the 13C-UBT proved to be an improved version of the U.S. standard 13C-UBT offering less expensive ingredients, shorter test duration, and a simplified breath test collection method, without sacrificing accuracy.
Authors: E J Melius; S I Davis; J T Redd; M Lewin; R Herlihy; A Henderson; J Sobel; B Gold; J E Cheek Journal: Epidemiol Infect Date: 2012-05-17 Impact factor: 4.434