Introduction
Ingestible sensors hold the promise to revolutionize the monitoring of gastrointestinal diseases, including inflammatory bowel disease (IBD). These miniature electronic capsules could provide a minimally-invasive, cost-effective, and patient-friendly alternative to traditional endoscopic procedures, with the promise of greatly enhancing disease tracking and management.
Aims & Methods
To enable real-time, minimally-invasive monitoring of gut health, we developed the Gastrointestinal Smart Module (GISMO), a highly miniaturized ingestible sensor (3 times smaller than video capsules) that measures redox balance, pH, and temperature throughout the GI tract.
Redox balance plays a key role in regulating the intestinal barrier and mediating interactions among the host, immune system, and gut microbiota. In conditions like IBD, gastrointestinal cancers, and irritable bowel syndrome (IBS), disruptions in immune response and shifts in the gut microbiome can destabilize the balance of oxidants and antioxidants1,2. This imbalance leads to oxidative stress, detectable through altered redox signals.
After validation in both lab and pre-clinical models, the GISMO system was tested in healthy participants.
Results
In this first-in-human trial, 66 sensors were administered to 15 healthy participants. The GISMO system demonstrated feasibility, safety, and ease of use. Participants reported ease in swallowing the sensors and expressed willingness to ingest multiple capsules. No device-related adverse events occurred throughout the study. GISMO is the first device capable of measuring in vivo redox balance, providing high-resolution data every 20 seconds. The data revealed consistent profiles from an oxidative environment in the stomach to a strongly reducing environment in the colon. This group of self-reported healthy volunteers exhibited low inter- and intra-subject variability, providing a reliable baseline for future comparative studies in patient populations.
Conclusion
This trial marks the first in vivo measurement of redox balance along the human gut, paving the way for new insights into the role of redox balance in maintaining gut homeostasis, inflammation, and the gut microbiome. The ability to conduct frequent and simple monitoring could revolutionize the way gastrointestinal diseases are tracked and managed.
References
1. Campbell, E. L. & Colgan, S. P. Control and dysregulation of redox signalling in the gastrointestinal tract. Nat Rev Gastroenterol Hepatol 16, 106–120 (2019).
2. Bourgonje, A. R. et al. Oxidative Stress and Redox-Modulating Therapeutics in Inflammatory Bowel Disease. Trends Mol Med 26, 1034–1046 (2020).
Disclosure
AE, FL, NVH, RA have filed a patent application on sensing in the gastrointestinal tract with the European (EP4197437A1) and U.S. (US20230190178A1) patent office. FL, AE, and RS have filed a patent application on measuring and localizing inflammation in the gut (application no. EP 24217111.4) with the European patent office. TTo, IDCM, AE, FL have filed a patent application on localization of an ingestible device (application no. EP24222150.5).