First tech-enabled clinical trial will use new biomarkers to measure effect of Seed's Daily Synbiotic on gut microbiome after antibiotic use
LOS ANGELES, Nov. 21, 2019 /PRNewswire/ -- Seed Health, a microbial sciences company, today announced a research partnership with digital health company, Atmo Biosciences, to use the world's first ingestible gas-sensing capsule 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 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," said 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, which is more reflective of the gut lumen microbiome, specifically in the colon. Other than an invasive tube insertion, 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.
To better understand the gut microbiome, scientists have sought new methodologies and biomarkers to safely and more precisely measure gastrointestinal activity.
The Atmo Gas Capsule, published in Nature Electronics, is the first ingestible sensor technology to track location-specific gases through the human gastrointestinal tract. The 28mm capsule uses sensors to measure key gases present, including hydrogen and oxygen, and is up to 3,000 times more accurate than breath tests. 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 data is transmitted every 6 minutes for up to 5 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, 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.
Seed®, the consumer health division of Seed Health, will use Atmo's Gas Capsule in a series of upcoming clinical studies on their flagship probiotic, the Daily Synbiotic. The first clinical study, authorized by Health Canada NHPD, will build on previous metagenomic studies and 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.
"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," said 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 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. Recruitment for this study is scheduled to begin in December with the trial commencing in early 2020.
"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," said Atmo Biosciences CEO, Mal Hebblewhite. "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."
About Seed Health
Seed Health is a microbial sciences company pioneering applications of bacteria to impact human and environmental health. In collaboration with leading academic partners, Seed Health's foundry model accelerates breakthrough science to develop live biotherapeutics and consumer innovations. The portfolio targets some of the most pressing, pervasive conditions for which microbes can become or replace the primary standard of care. Seed Health's first foundry company is LUCA Biologics, a biotechnology company developing a new class of living medicines targeting the vaginal microbiome to impact reproductive and urogenital health.
Seed develops broad spectrum and targeted consumer probiotics from strain-specific research validated in human clinical trials. Seed's platform is built on a global strain bank, and includes technology-enabled gastrointestinal simulation models, human cell line and antibiotic resistance testing, untargeted metabolomics and whole genome sequencing. Seed's life science approach brings much-needed precision, efficacy and education to the global probiotics market. Seed is the consumer division of Seed Health.
About Atmo Biosciences
Atmo Biosciences is a digital health business underpinned by a world-first ingestible gas-sensing capsule technology developed at RMIT University. When swallowed, the Atmo Gas Capsule can profile the gas biomarkers within the gut in real-time, leading to better diagnosis and assessment of treatments for gastrointestinal disorders, and the monitoring of microbiome function, leading to improved gut health and wellness.
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