Ingestible Device for Gastric Fluid Sampling

Abstract

The composition of the human gastrointestinal microbiota is linked to the health of the host, and interventions targeting intestinal microbes may thus be designed to prevent or mitigate disease. As the spatiotemporal structure and physiology impact the residing bacterial community, local sampling is gaining attention, with various ingestible sampling devices being developed to target specific sites. However, the stomach has received limited attention, despite its potential downstream influence. This work presents a simple ingestible device for gastric fluid sampling and outlines a series of characterizations to ensure device safety, reliability, and accuracy. In vitro testing determined seal effectiveness, mechanical integrity, biocompatibility, and device-sample inertness. In situ and ex vivo testing confirmed sampling accuracy, demonstrated microbiome composition stability for at least 24 h, and differentiation of microbiota between two primates. 16S rRNA gene amplicon sequencing of samples from a porcine ingestion model showed that samples resembled post-mortem gastric samples and differed from fecal and colonic samples. Also addressed in this study, is production scalability and shelf-life to facilitate the safe and effective deployment of devices in clinical settings.