Phase IV noninferiority controlled randomized trial to evaluate the impact on diagnostic thinking and patient management and the test–retest reproducibility of the Gaxilose test for hypolactasia diagnosis

摘要

Background:The diagnostic accuracy of the Gaxilose test (GT) for hypolactasia diagnosis has already been proved. The objectives of this clinical trial were to demonstrate the noninferiority of the GT compared to the hydrogen breath test (HBT) on the impact on diagnostic thinking and patient management, to evaluate the GT reproducibility with urine accumulated from 0 to 4 hours and from 0 to 5 hours and to assess test safety.