Evaluation of a digital handheld hydrogen breath monitor to diagnose lactose malabsorption: Interventional crossover study

Background: Lactose malabsorption is a common condition that affects a broad segment of the population. Clinical diagnosisbased on symptom recall can be unreliable and conventional testing can be inconvenient, requiring expensive laboratory-basedequipment and conduction of the testing in a clinical setting.Objective: The aim of this study is to assess the performance of a digital handheld hydrogen breath monitor (GIMate) indiagnosing lactose malabsorption compared to a US Food and Drug Administration (FDA)-cleared device (H2 Check) for thesame indication.Methods: An interventional crossover study was performed in adult participants with a prior confirmed diagnosis of lactosemalabsorption or a suspected history of lactose intolerance.Results: A total of 31 participants (mean age 33.9 years) were enrolled in the study. There was 100% positive percent agreementand 100% negative percent agreement between the GIMate monitor and the H2 Check. Correlation between gastrointestinalsymptoms and hydrogen values was positive at 0.82 (P<001).Conclusions: The digital handheld GIMate breath monitor achieved equivalent diagnostic performance to that of an FDA-cleareddevice in the diagnosis of lactose malabsorption.