The safety and sensitivity of a telemetric capsule to monitor gastrointestinal hydrogen production in vivo in healthy subjects: a pilot trial comparison to concurrent breath analysis. Issue 6 (1st August 2018) - Berean, Kyle J.
Summary: Background: Intestinal gases are currently used for the diagnosis of disorders including small intestinal bacterial overgrowth and carbohydrate malabsorption. Aim: To compare the performance of measuring hydrogen production within the gut directly with the telemetric gas‐sensing capsule with that of indirect measurement through breath testing. Methods: Using standard breath testing protocols, the capsules and breath tests were simultaneously evaluated in a single‐blinded trial in 12 healthy subjects. Eight received a single dose of 1.25‐40 g inulin and four 20 or 40 g glucose. Safety and reliability of the capsules were also assessed. Results: There were no reported adverse events. All capsules were retrieved and operated without failure. Capsule measurements were in agreement with breath test measurements in magnitude but not in timing; minimal hydrogen production was observed after glucose ingestion and capsule measurements correlated with breath hydrogen after ingestion of 40 g inulin. A dose‐dependent increase in concentration of hydrogen was observed from the capsule following ingestion of inulin as low as 1.25 g compared with >10 g for breath measurements. Specifically, the capsule measured >3000 times higher concentrations of hydrogen compared to breath tests, resulting in a signal‐to‐noise ratio of 23.4 for the capsule compared to 4.2 for the breath test. Conclusions: The capsule showed high sensitivity and signal‐to‐noise ratio in measuring luminal hydrogen concentrations, provided information on the site of intestinal gas production, and demonstrated safety and reliability. The capsule has potential for improving diagnostic precision for disorders such as small intestinal bacterial overgrowth.