The trials conducted by researchers at RMIT University have exposed mechanisms in the human body that have never been observed before, including a promising new immune system.
The new technology and discoveries provide a vital game-changer for the one-in-five people globally who will suffer from a gastrointestinal disorder during their lifespan. They could also result in fewer invasive procedures like colonoscopies.
The ingestible capsule, about the size of a vitamin pill, detects and measures gut gases – carbon dioxides, hydrogen, and oxygen – in real time. This data can be transmitted to a mobile phone.
Professor Kourosh Kalantar-zadeh, research lead and capsule co-inventor, said the trials revealed that the human stomach uses an oxidizer to combat foreign bodies in the gut.
“We found that the stomach releases oxidizing chemicals to break down and beat foreign compounds that are staying in the stomach for longer than usual,” Kalantar-zadeh said.
“This could represent a gastric protection system against foreign bodies. Such an immune mechanism has never been reported before.”
Another new discovery from the trial was that there may be oxygen present in the colon.
“Trials showed the presence of high concentrations of oxygen in the colon under an extremely high-fibre diet,” Kalantar-zadeh said. “This contradicts the old belief that the colon is always oxygen free.
“This new information could help us better understand how debilitating diseases like colon cancer occur.”
The trials were carried out on seven healthy individuals on low and high-fiber diets. Results revealed that the capsule accurately displays the onset of food fermentation, emphasizing their potential to clinically monitor digestion and typical gut health.
The trials also revealed that the capsule could provide a much more effective approach to measuring microbiome activities in the stomach, a critical way of defining gut health.
“Previously, we have had to rely on faecal samples or surgery to sample and analyse microbes in the gut,” Kalantar-zadeh said.
“But this meant measuring them when they are not a true reflection of the gut microbiota at that time. Our capsule will offer a non-invasive method to measure microbiome activity.”
Now that the capsule has positively passed human trials, the team is aiming to commercialize the technology.
Co-inventor Dr Kyle Berean said: “The trials show that the capsules are perfectly safe, with no retention.
“Our ingestible sensors offer a potential diagnostic tool for many disorders of the gut from food nutrient malabsorption to colon cancer. It is good news that a less invasive procedure will now be an option for so many people in the future.
“We have partnered with Planet Innovation to establish a company called Atmo Biosciences and bring the product to market.
“This will lead to Phase II human trials, and help raise the funds needed place this safe and revolutionary gut monitoring and diagnostic device into the hands of patients and medical professionals.”
The trials were done along with colleagues from Monash University.
Details of the research are published in the inaugural volume of Nature Electronics.