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. 2024 Dec;69(12):4430-4436.
doi: 10.1007/s10620-024-08583-7. Epub 2024 Aug 10.

Validation of a Hand-Held Point-of-Care Device to Measure Breath Hydrogen and Its Utility in Detecting Response to Antibiotic Treatment

Guillermo Barahona  1 , Barry Mc Bride  2 , Áine Moran  2 , Ricky Harrison  2 , Luisa Villatoro  1 , Robert Burns  1 , Bo Konings  1 , Robert Bulat  1 , Megan McKnight  1 , Glenn Treisman  3 , Pankaj J Pasricha  4   5
Affiliations

Validation of a Hand-Held Point-of-Care Device to Measure Breath Hydrogen and Its Utility in Detecting Response to Antibiotic Treatment

Guillermo Barahona et al. Dig Dis Sci. 2024 Dec.

Abstract

Background: Breath testing for small intestinal bacterial overgrowth (SIBO) is typically performed using clinic-based equipment or single-use test kits.

Aims: This study aimed to evaluate the utility of a portable, point-of-care breath analysis device (AIRE®, FoodMarble) in patients suspected to have SIBO. A technical assessment including a comparison to existing mail-in kits was first performed. Then, postprandial breath hydrogen levels of patients before and after antibiotic treatment were gathered and compared to levels seen in a healthy cohort.

Methods: For the comparison, 50 patients suspected of having SIBO were provided with an AIRE device and performed concurrent LHBTs at-home with a mail-in breath test kit. For the postprandial analysis, twenty-four patients with chronic GI symptoms measured their postprandial hydrogen for 7 days prior to antibiotic treatment and for 7 days after treatment. 10 healthy controls also measured their postprandial hydrogen for 7 days.

Results: Substantial agreement was demonstrated between AIRE and the mail-in kits for the performance of lactulose hydrogen breath tests (κ = 0.8). Prior to treatment, patients had significantly greater daily postprandial hydrogen than healthy controls (p < 0.001). The mean postprandial hydrogen of patients reduced significantly after treatment (p < 0.001).

Conclusions: Measuring postprandial hydrogen shows potential as a means of differentiating patients with chronic GI symptoms from healthy controls and may be useful in monitoring patients before, during, and after treatment. Future studies could help determine if pre-treatment breath gas levels are predictive of response to antibiotic treatment.

Keywords: Digital health; Personal breath test device; Postprandial breath hydrogen; Remote patient monitoring; Remote testing.

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Conflict of interest statement

Declarations. Conflict of interest: Áine Moran, Barry Mc Bride, and Ricky Harrison are employees of FoodMarble Digestive Health. Pankaj Jay Pasricha is a member of the clinical advisory board of FoodMarble Digestive Health and a paid consultant. The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Linearity and repeatability curve for three AIRE devices tested at 3, 10, and 50 ppm H2/air on three non-consecutive days
Fig. 2
Fig. 2
A Mean breath H2 concentrations collected during the LHBT using AIRE (n = 50). B Mean breath H2 concentrations collected during the LHBT using the mail-in kit (n = 50)
Fig. 3
Fig. 3
A comparison of postprandial hydrogen from patients pre-treatment (n = 24) and post-treatment (n = 24) to healthy volunteers (n = 10)
See this image and copyright information in PMC

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