FoodMarble AIRE, a portable hydrogen breath tester, recently completed its first clinical trial with Johns Hopkins.
The new tester was developed by Irish digital digestive health startup FoodMarble, marking the world's first personal tracker for the digestive tract. FoodMarble AIRE is a commercially available portable hydrogen breath tester that can connect to a smartphone app via Bluetooth. This portability allows for immediate results, helping users better optimize their diet with assistance from a long-standing clinical technology fitted in a handheld, personal device.
Its portable nature empowers users to collect large amounts of significant data from the comfort of their own homes. Digital health and data collection, in turn, can guide medical diagnosis, treatment, and ongoing management of a patient's health.
"The COVID pandemic has emphasized the need to adopt innovative tools to maintain important patient testing. AIRE enables the patient to test in the safety and comfort of their own home," says Dr. Robert Ganz, clinical advisor to FoodMarble. He explains that the new tester gives the patient the ability to check their response to antibiotics with repeat testing.
A New Generation of SIBO Investigation and Monitoring
One of its main applications is in the monitoring of Small Intestinal Bacterial Overgrowth (SIBO), which, according to a Mayo Clinic article, is a condition caused by an abnormal increase in the bacterial population in the small intestine, especially bacteria that is not native and common to the site. While colonic fermentation is a natural process that occurs during digestion, people suffering from SIBO would see non-native bacteria acting to ferment the person's recently taken meal.
SIBO then creates a host of unpleasant and even debilitating symptoms: bloating, abdominal pain, irregular bowel movements, and even nausea.
The prevalence of SIBO in the general population remains largely unknown, with studies suggesting that it might be present for up to 15% of healthy individuals. It is also largely associated with a range of other common clinical problems, particularly irritable bowel syndrome (IBS), where 40% - 80% of IBS patients also have SIBO.
"SIBO relapse is also very common and can occur within months of the initial clearance of infection. Therefore, monitoring with AIRE can help us identify the early signs of relapse before the infection reoccurs," Ganz added.
Passing Its First Clinical Trial with Johns Hopkins
The capabilities of FoodMarble AIRE make it a great tool for keeping an eye for possible cases of SIBO from the comfort of the household, leading Johns Hopkins, one of the world's leading institutions in gastroenterology, to conduct a successful first clinical trial. Aside from testing the efficacy of the new portable hydrogen breath tester, Johns Hopkins looks at whether FoodMarble AIRE could assist in the diagnosis of SIBO. Also, the medical center examines whether the collection of real-world, longitudinal data can lead to more accurate diagnoses of SIBO in the future.
In the Johns Hopkins clinical trial, FoodMarble AIRE was compared to Lactulose hydrogen breath testing (LHBT), currently recognized as the gold standard in SIBO diagnosis. Breath testing is the preferred technology because it is patient-friendly and non-invasive. However, it remains a standalone test conducted in a clinic for several hours. Additionally, accuracy varies depending on the test protocols and result interpretation.
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