Improving the Diagnosis of SIBO Using an At-Home Handheld App Connected Breath Analysis Device (AIRE)

INTRODUCTIONSmall Intestinal Bacterial Overgrowth (SIBO) is a common yet underdiagnosed condition. Lactulose hydrogen breath tests (LHBT) are typically used to detect SIBO; however, current breath testing methods require specialised, expensive equipment and technical support and are either done at a point-of-care facility and/or have to be mailed to a central laboratory. To address these issues a novel hand-held breath analyzer (AIRE(R), FoodMarble) was tested. The aims of this study were first, to perform a technical assessment of the AIRE device, second to compare the performance of the AIRE device against a commercially available mail-in LHBT kit using a zero-inflated negative binomial mixed effect model. METHODSThree AIRE devices were tested with certified test gases covering a diagnostically meaningful range (hydrogen mixed with air at 3 ppm, 10 ppm and 50 ppm). For the clinical study, 36 patients suspected to have SIBO presenting to a tertiary level clinic were provided with an AIRE device and performed concurrent LHBTs at home with a mail-in LHBT kit. RESULTSThe overall average readings (mean {+/-} SD) for the AIRE devices tested at 3 ppm, 10 ppm and 50 ppm H2 were: 3.5 {+/-} 0.7 ppm; 10.7 {+/-} 1.1 ppm and 49.5 {+/-} 2.6 ppm respectively. The overall mean absolute error across the tested devices was 1.2 ppm. A significant positive correlation (r = 0.78, p < 0.001) was demonstrated between AIRE and mail-in kit H2 values. DISCUSSIONThe AIRE device is a compelling alternative to mail-in LHBT kits for the diagnosis of SIBO. The AIRE device may also offer advantages over other traditional breath testing methods.