Development of a swallowable diagnostic capsule to monitor gastrointestinal health

At DDW 2019, we presented results of a proof-of-concept study evaluating the function of a diagnostic platform that includes an autonomous, swallowable capsule for in situ biomolecular detection of small intestinal bacterial overgrowth (SIBO).

SIBO is under-diagnosed, and significant limitations exist with currently available diagnostic testing methods. The effectiveness of breath testing in evaluating SIBO is limited as there is no consensus on methodology, there are confounding factors to accurate measurement, sensitivity and specificity are limited, and the technique is not FDA approved for evaluation of SIBO. As a result, patients with SIBO are poorly served.

This bacterial detection smart capsule platform was designed to serve this unmet need by providing an aid to the diagnosis of SIBO that would offer the sensitivity and reproducibility of the aspirate and culture method but with the comparable turnaround time, cost and non-invasive nature as the breath test. The platform has three components: a single-use capsule that is swallowed by a patient with suspected SIBO, a wearable wireless receiver, and analysis software. The capsule determines its location in the digestive tract, collects a sample, and performs an onboard assay to measure bacterial load. The results of the assay are wirelessly communicated from the wearable receiver to the software for review by the healthcare provider.