A collaboration between microbial sciences company Seed Health and Atmo Biosciences – a digital health company – will see an ingestible gas-sensing capsule technology monitor key gases produced within the gut in real-time. Atmo’s gas capsule, which tracks location-specific gases through the human gastrointestinal (GI) tract, will be used to examine the Daily Synbiotic – the flagship probiotic of Seed, the consumer health division of Seed Health. The first trial will evaluate the impact of probiotics on the gut microbiome after antibiotic use.
“The Atmo Gas Capsule is the first device that measures the concentration of various gases at the source of production in the GI tract in real-time. That data can be leveraged for a wide array of applications, from helping to diagnose GI disorders to understanding baseline gut functioning to testing the efficacy of various therapies,” Raja Dhir, Co-CEO and Co-Founder of Seed Health, tells.
The 28 mm capsule uses sensors to measure key gases present, including hydrogen and oxygen and is touted as being up to 3,000 times more accurate than breath tests. For up to five days after ingestion, the data is transmitted every six minutes to a small receiver, which then transmits the data via Bluetooth to a phone for ease of monitoring by users, researchers and clinicians.
Patients enrolled in this first study will swallow an Atmo Gas Capsule for continuous monitoring, detection and measurement of key gases and volatile compounds. After the capsule has passed through the gut, it then exits intact within the stool and is discarded. Additionally, the study will collect urine, vaginal swabs and fecal and blood samples at multiple unique time points.
This first clinical study, authorized by Health Canada NHPD, will build on previous metagenomic studies. It will measure both the effects of antibiotics on the entire GI tract and how the use of specific strains of probiotic bacteria may impart functional benefits to the GI system after antibiotic therapy. Recruitment is scheduled to begin in December, with the trial commencing in early 2020.
The teams’ overall thesis is to develop trials using fully integrated data sets to look at physical or physiological parameters, like the effects of an intervention on the host. However, they also hope that the findings will lead to a deeper understanding of the overall microbial community in the gut. They will collect data on markers that have not been previously available to microbiome researchers – intestinal transit time (how quickly material moves through the intestine), and microbe location throughout the gut.
“We believe that these types of integrated data sets are necessary to develop effective interventions for gut health and to develop better diagnostic methods for GI disorders. We’ve worked hard to create a strong trial design, and anticipate a quick enrollment process and smooth trial execution,” says Dhir.
This is not the first time technology is being used to track changes in the gut, as the personalized nutrition sector continues to grow. Irish start-up FoodMarble produces a portable breath test and app used to measure and track digestive health. The company has partnered with Carbiotix to examine whether breath hydrogen can be used as a non-invasive, real-time measure of changes in microbiome composition.
Challenges in the gut
As the lower gut is challenging to reach physically, it can be difficult to study at a clinical level. To date, gut microbiome research – and studies on the efficacy of interventions like probiotics – has relied largely on stool analysis. However, this is more reflective of the gut lumen microbiome, specifically in the colon. There are other limitations, including cost, accuracy and invasiveness of alternative diagnostic methods such as tube insertion, breath measurements, biopsy, endoscopy, motility pills and imaging pills.
“Clinical interest in the gut microbiome is at an all-time high, as new research continues to be published showing the microbiome’s outsized influence on general health. However, the field of microbiome research is still in its infancy, and is in need of integrated data sets to build a more complete understanding of the gut,” notes Dhir.
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. The company highlights that these new biomarkers empower researchers to gain objective, real-time insight into patient gut health for diagnosis, treatment, as well as how interventions like antibiotics, probiotics and food may impact gut function.
This is crucial as antibiotics are known to negatively impact the diversity and function of the gut microbiome, despite being a key frontline tool to treat and eliminate infections. A recent Chr. Hansen-sponsored study found that over two million antibiotic courses could be avoided each year if the US population took probiotics.
However, further research in the microbiome space is crucial, with Nestlé announcing its partnership with the University of California San Diego Center for Microbiome Innovation earlier this week. The collaboration will reinforce research into the microbiome’s impact on human health and aims to accelerate the development of innovative nutritional solutions promoting health and wellbeing.