Steps are being taken toward human clinical trials for the precision measurement of the intestinal microbiome.
Researchers at Tufts University School of Engineering have made remarkable strides in developing a small, pill-sized device that can be swallowed to traverse the gastrointestinal tract, providing a comprehensive sampling of the microorganisms present within it.
This device has the potential to advance research on the relationship between resident bacteria and a wide range of health conditions. It could also serve as a diagnostic tool for adjusting the microbiome or administering drugs to treat those conditions.
The device has completed preclinical characterization – as presented in the journal Device – paving the way for upcoming human clinical trials. It is characterized by a 3D-printed soft elastic exterior with sidewall inlets that open in response to the changing acidity as the pill reaches the small intestine. The pill uses elastic microvalves with swellable polyacrylate beads that close the inlets once intestinal content has been collected.
The technology was developed at Tufts Nano Lab by a team led by Professor Sameer Sonkusale, along with post-doctoral researcher Ruben Del-Rio-Ruiz who is lead author on the preclinical study. A second team of researchers led by Professor Giovanni Widmer at the Cummings School of Veterinary Medicine at Tufts University assisted by PhD candidate Debora Silva, performed the tests in animals and analyzed the samples collected by the pill.
Technological Enhancements and Benefits
Improvements over previous versions of the pill include using a soft elastic exterior rather than a rigid shell, to make it easier to ingest, and significantly improved control over localized sampling of the microbiome in the small intestine.
Current techniques to study the intestinal microbiome primarily rely on fecal matter, This technology represents a significant advance in understanding the function of the thousands of microbial species populating the entire length of the gastrointestinal tract and their effects on health.
Reference: “Soft autonomous ingestible device for sampling the small-intestinal microbiome” by Ruben Del-Rio-Ruiz, Debora Regina Romualdo da Silva, Hasika Suresh, Hannah Creasey, Cihan Asci, Danilo M. dos Santos, Atul Sharma, Giovanni Widmer and Sameer Sonkusale, 20 June 2024, Device.
DOI: 10.1016/j.device.2024.100406
The study was funded by the National Institutes of Health.