Real-time diagnostic capsule for gut diseases in clinical trials

A gas-sensing capsule you can swallow could revolutionise the way that gut disorders and diseases are diagnosed and prevented.

One-in-five people worldwide suffer from a gastrointestinal disorder. This ingestible capsule, the size of a vitamin pill, could prevent the need for many invasive colonoscopies by detecting and measuring gut gases – hydrogen, carbon dioxide and oxygen – in real time, and at known locations, as the capsule passes through the patient’s gut.

Developed by Prof. Kourosh Kalantar-Zadeh and his team while at RMIT University, the gas-sensing capsule is being commercialised by start-up, Atmo Biosciences Pty Ltd. It is a world-first, patented solution that can accurately profile the distinctive mix of gases within the gut, providing real-time insights into microbiome function and enabling better diagnosis and treatment for disorders such as irritable bowel syndrome and small intestinal bacterial overgrowth.  Nanocomposite membranes are used to separate the gases and during the development phase these were analysed using a variety of microscopy techniques at the Microscopy Australia Linked Lab at RMIT, the RMIT Microscopy and Microanalysis Facility.

Some of the key benefits of the gas sensing capsule over previous diagnostic methods for gut gasses and microbiome include:

• It circumvents more invasive procedures and is less expensive
• It is small and easy to swallow
• It provides real time direct sensing at known locations within the gut
• It is up to 10,000 times more accurate than current standards
• Patient data can be aggregated for clinical analysis and application of predictive algorithms

Phase 1 human trials of a prototype gas capsule established that the capsules were safe and reliable, and far more accurate than breath tests in detecting gaseous biomarkers.

Several more human trials of the capsule are underway at Monash University and the Alfred Hospital.

The first trial is investigating the accuracy of gut motility measurements and transit time in 60 healthy subjects, and comparing the capsule’s performance with other methods.

The second trial investigates Irritable Bowel Syndrome (IBS) patients, who suffer from debilitating symptoms that negatively affect their quality of life.

“IBS affects 10% of the population, but there is currently no definitive diagnostic test or biomarker; diagnosis, treatment and management is challenging because it is based almost entirely on symptoms,” Atmo Biosciences CEO, Mal Hebblewhite said.

“The Atmo Gas Capsule provides researchers and clinicians with insight into microbiome function using a digital biomarker, enabling them to assess the impact of personalized therapies on the gut in real time.”