Tufts Nano Lab’s ingestible microbiome sampling pill to enter human clinical trials stage

13 Jun 2024 --- An ingestible microbiome sampling pill being developed by the Tufts Nano Lab at the Tufts University School of Engineering, US, will be put to the test in an upcoming human clinical trial. The researchers note the pill “has the potential to transform gut health research.”

The device, with the shape and size of a vitamin pill, can be swallowed. It then passes through the gastrointestinal tract, sampling the full inventory of microorganisms in it. 

The implications of the full development of such a device for the advancement of gut health research are wide reaching. In particular, it could facilitate studies into the relationship between resident gut bacteria in a range of health conditions.

It could also help the diagnosis of various health issues related to the gut microbiome, as well as to the administration of medicine to treat such conditions.

Studying the gut 
Preclinical characterization for the device is now completed, which means the start of human clinical trials is to be expected. 

The pill device has a 3D-printed, soft and elastic exterior with “sidewall intels,” which are triggered by acidity, meaning that they can open up upon reaching the small intestine, as they are triggered by the pH levels in that environment.

The device has the shape and size of a vitamin pill, making it easy to swallow, pass through, investigate and collect samples from the gastrointestinal tract.It uses elastic microvalves with swellable polyacrylate beads. These are able to close the inlets when the intestinal content has been collected. 

This gut research innovation is the work of a team led by Tufts University professor Sameer Sonkusale, along with post-doctoral researcher Ruben Del-Rio-Ruiz who is lead author on the preclinical study.

The pill device has already been tested on animals by another team, led by professor Giovanni Widmer at the Cummings School of Veterinary Medicine at Tufts University and including Ph.D. candidate Debora Silva, who analyzed the collected samples. 

Technical capsules 
This recent development builds upon previous versions of the pill, which had a rigid rather than a soft outer layer. This improves the sampling process by making the device easier to swallow and more pill-like. At the same time, it improves the control over the localized sampling of the microbiome in the small intestine.

According to the researchers, the new device can “significantly advance” scientific understanding of the function of the thousands of microbial species living along the entire gastrointestinal tract and the ways in which they affect health. Presently, the main approach to testing and exploring the intestinal microbiome is the investigation of fecal matter. 

Last year, researchers of the Laureate Institute for Brain Research in Oklahoma, US, also employed a technical capsule to further research in the gut. Study participants swallowed a vibrating capsule, as a new way to measure the neural processes originating from the gut, which could transform the current clinical approach. 

By Milana Nikolova