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Evaluation of a Digital Handheld Hydrogen Breath Monitor to Diagnose Lactose Malabsorption: An Interventional Crossover Study
Simon C. Mathews;
Sandy Templeton;
Stephanie K. Taylor;
Sten Harris;
Margaret Stewart;
Shruti M. Raja
ABSTRACT
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 were enrolled in the study. There was 100% positive percent agreement and 100% negative percent agreement between the GIMate monitor and the H2 Check.
Conclusions:
The digital handheld GIMate breath monitor achieved equivalent diagnostic performance in the diagnosis of lactose malabsorption. Clinical Trial: ClinicalTrials.gov NCT04754724
Citation
Please cite as:
Mathews SC, Templeton S, Taylor SK, Harris S, Stewart M, Raja SM
Evaluation of a Digital Handheld Hydrogen Breath Monitor to Diagnose Lactose Malabsorption: Interventional Crossover Study