Atmo Biosciences recruits participants for clinical trial testing smart capsules that monitor gut health
10 Aug 2023 --- Atmo Biosciences launches a clinical study to assess the use of its Atmo gas capsule to measure the gastrointestinal transit time in patients with suspected motility disorders. This gas-sensing capsule provides insights into gut health and microbiome function, which can potentially support treatments for digestive issues like irritable bowel disease.
In the upcoming trial, participants will ingest the capsule to assess its ability to take measurements, such as temperature and the transit time of gas, as it travels through the different regions of the gut. It then transmits these data to provide insights into the location of the capsule, microbiome function and gut health.
The researchers will compare the Atmo gas capsule’s performance with the SmartPill device, a similar product already on the market.
Atmo Biosciences aims to present their study findings to the FDA as it applies for marketing clearance for the device in the US.
“We are excited to commence recruiting patients for this pivotal study to support our initial clinical indication, the evaluation of motility disorders,” says Malcolm Hebblewhite, Atmo Biosciences president and CEO.
“This is a crucial step for the business and will be used to support our submission for regulatory clearance with the FDA in 2024, paving the way for product launch in the important US market.”
Competitor analysis
Atmo Biosciences aims to recruit 100 participants with functional gastrointestinal symptoms and dysmotility at 13 sites across the US and Australia.
Participants will ingest the Atmos gas capsule and SmartPill to assess the transit time of gas. Atmo Biosciences notes that gasses are important biomarkers of disease, dysfunction and dysbiosis.
Atmo Biosciences aims to recruit 100 participants to test the performance of its capsules (Image credit: Atmo Biosciences). SmartPill uses pH, temperature and pressure to identify when the pill moves through different gut regions. In contrast, the Atmo capsule uses measures such as hydrogen and carbon dioxide concentration and temperature.
“We are excited to be evaluating Atmo against the SmartPill in measuring gastric emptying and colonic transit time through continuous measurement in dysmotility patients,” says Professor William D. Chey, co-lead investigator of the study and chief of Gastroenterology and Hepatology at the University of Michigan, US.
“Dysmotility disorders, such as gastroparesis and chronic constipation, affect millions of people yearly. Patients can experience chronic, debilitating symptoms such as nausea, vomiting, bloating, abdominal pain and abnormal bowel habits.”
Gastrointestinal disorders
Atmo Biosciences states its capsule can help clinicians diagnose motility disorders such as gastroparesis – delayed emptying from the stomach – and slow transit constipation.
“As many gastrointestinal disorders share similar symptoms, more diagnostic tools are needed to help clinicians pinpoint the problem,” notes co-lead investigator Dr. Braden Kuo, director of the Center for Neurointestinal Health at Massachusetts General Hospital and Associate Professor at Harvard Medical School, US.
“The Atmo capsule shows great potential as a diagnostic tool for motility disorders, and we are happy to have this trial underway to test its safety and efficacy.”
There is a growing awareness among consumers and brands of the importance of gut health and how this links to overall health. Research into the gut-brain axis is progressing, for example, linking gut health to anxiety, depression and other mental health related conditions.
Follow-up successful pilot
The upcoming trial follows several pilot trials that compared transit measurements from the Atmo capsule with the SmartPill.
Atmo claims that a previous trial comparing both products found that its capsule was the only tool that could detect a shift in the distribution of fermentation in the colon in patients with irritable bowel syndrome whose diets were shifted.
The capsule may help clinicians better characterize and measure the distribution of fermentation along the digestive tract, the company underscores.
Dr. Vincent Ho, a clinical academic gastroenterologist at Western Sydney University, Australia, comments: “I am delighted to be involved in this study following my involvement in the successful Atmo dysmotility pilot trial, which has helped inform the pivotal study design.”
“During both the pilot and now the pivotal trial, we have found patients willing to embrace this technology to help diagnose their gastrointestinal problems.”
By Jolanda van Hal
