Evaluation of a Digital Handheld Hydrogen Breath Monitor to Diagnose Lactose Malabsorption: An Interventional Crossover Study.

Background Lactose malabsorption is a common condition that affects a broad segment of the population. Clinical diagnosis based on symptom recall can be unreliable and conventional testing can be inconvenient, requiring expensive lab-based equipment conducted in a clinical setting. Objective To assess the performance of a digital handheld hydrogen breath monitor (GIMate) in diagnosing lactose malabsorption compared to an FDA cleared device (H2 Check) for the same indication. Methods An interventional crossover study was performed in adult participants with a prior confirmed diagnosis of lactose malabsorption or a suspected history of lactose intolerance. Results Thirty-one participants (mean age 33.9 years) were enrolled in the study. There was 100% positive percent agreement and 100% negative percent agreement between the GIMate monitor and the H2 Check. Correlation between gastrointestinal symptoms and hydrogen values was positive at 0.82 (P Conclusions The digital handheld GIMate breath monitor achieved equivalent diagnostic performance in the diagnosis of lactose malabsorption. Clinicaltrial ClinicalTrials.gov NCT04754724.