Ingestible gas sensor to monitor gut microbiome in clinical trials
The partnership will use the technology in clinical trials to profile key gases produced within the gut in real time. The first trial will evaluate the impact of probiotics on the gut microbiome – the microbe population living in the body’s digestive tract – after antibiotic use.
“Despite over a decade of human microbiome research, we are still limited by the technologies available to measure and understand real-time activity in the human gut,” says Raja Dhir, Seed Health co-founder and co-CEO. “We are inspired by this collaboration with Atmo Biosciences as we pioneer new biomarkers and methods to measure the impact of specific probiotics, while deepening our functional understanding of the gut microbiome. The ability to monitor this environment has tremendous implications for the future of the field.”
The lower gut is challenging to reach physically, making it difficult to study clinically. To date, gut microbiome research — and studies on the efficacy of interventions like probiotics – has relied largely on stool analysis.
Other than an invasive tube insertion, says the company, the only way to test for key gases is by breath measurements, which are often inaccurate as gas concentrations in the gut are 5,000-10,000 times higher than the breath. Other diagnostic methods such as aspiration, biopsy, endoscopy, motility pills, and imaging pills are also often highly invasive, costly, or have other clinical limitations.
The Atmo Gas Capsule – as described in an article in Nature Electronics – is the first ingestible sensor technology to track location-specific gases through the human gastrointestinal tract. The 28-mm capsule uses sensors to measure key gases present, including hydrogen and oxygen, and is up to 3,000 times more accurate than breath tests. After the capsule has passed through the gut, it then exits intact within the stool, and is discarded.
Atmo Biosciences CEO, Mal Hebblewhite says, “Working with Seed Health, we can now expand the potential of our technology to understand and measure the real-time impact of interventions like probiotics under different conditions. Our technology unlocks new datasets and novel biomarkers that could not only impact the millions who currently suffer from GI disorders and food intolerances, but also offer an entirely new dimension of research to evaluate interventions and preventive measures, which could impact millions more.”
According to the company, development is underway to include additional biomarkers such as methane, hydrogen sulfide, and short-chain fatty acids – an additional cluster of biomarkers key to understanding gut microbiota function. Data is transmitted every six minutes from the capsule for up to five days to a small receiver, which then transmits the data via Bluetooth to a mobile phone for ease of monitoring by users, researchers, and clinicians.
Collectively, say the companies, these new biomarkers empower researchers to gain objective, real-time insight into patient gut health for diagnosis, treatment, and how interventions like antibiotics, probiotics, and food may impact gut function. In upcoming series of clinical studies, Seed, the consumer health division of Seed Health, will use the gas capsule to study the effects of their flagship probiotic, the Daily Synbiotic, on gut microbiota.
Specifically, the first clinical study will measure both the effects of antibiotics on the entire gastrointestinal (GI) tract, and how the use of specific strains of probiotic bacteria may impart functional benefits to the GI system after antibiotic therapy.
“While antibiotics are a key frontline tool to treat and eliminate infections, they’re also known to negatively impact the diversity and function of the gut microbiome as reflected in the variety of side effects they cause,” says Dr. Gregor Reid, Distinguished Professor at Western University and Lawson Institute Chair of Human Microbiology and Probiotics, and Seed’s Chief Scientist. “As a research and clinical tool, this device will contribute greatly to learning how interventions, including probiotics, alter the gut microbiome’s activity and metabolic readouts.”
Patients enrolled in the first study, authorized by Health Canada NHPD, will swallow an Atmo Gas Capsule for continuous monitoring, detection, and measurement of key gases and volatile compounds. Recruitment for the study is scheduled to begin in December with the trial commencing in early 2020.
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