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

Authors :
Mathews SC
Templeton S
Taylor SK
Harris S
Stewart M
Raja SM
Source :
JMIR formative research [JMIR Form Res] 2021 Oct 18; Vol. 5 (10), pp. e33009. Date of Electronic Publication: 2021 Oct 18.
Publication Year :
2021

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 laboratory-based equipment and conduction of the testing in a clinical setting.<br />Objective: The aim of this study is to assess the performance of a digital handheld hydrogen breath monitor (GIMate) in diagnosing lactose malabsorption compared to a US Food and Drug Administration (FDA)-cleared device (H2 Check) for the same indication.<br />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.<br />Results: A total of 31 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<.001).<br />Conclusions: The digital handheld GIMate breath monitor achieved equivalent diagnostic performance to that of an FDA-cleared device in the diagnosis of lactose malabsorption.<br />Trial Registration: ClinicalTrials.gov NCT04754724; https://clinicaltrials.gov/ct2/show/NCT04754724.<br /> (©Simon C Mathews, Sandy Templeton, Stephanie K Taylor, Sten Harris, Margaret Stewart, Shruti M Raja. Originally published in JMIR Formative Research (https://formative.jmir.org), 18.10.2021.)

Details

Language :
English
ISSN :
2561-326X
Volume :
5
Issue :
10
Database :
MEDLINE
Journal :
JMIR formative research
Publication Type :
Academic Journal
Accession number :
34544034
Full Text :
https://doi.org/10.2196/33009