One of the world’s leading centers in gastroenterology has concluded a clinical trial to investigate the use of a remote-monitoring device and app to assist clinicians in the diagnosis of small intestinal bacterial overgrowth.
The trial at Johns Hopkins Medicine, led by Prof. Jay Pasricha M.D., has sought to validate the use of FoodMarble’s portable hydrogen breath tester, to assist in the diagnosis of SIBO. They also wanted to understand whether the collection of real-world, longitudinal data can help to more accurately diagnose SIBO in future
The FoodMarble AIRE is the world’s first personal digestive tracker. FoodMarble AIRE, is a commercially available, personal hydrogen breath test device that connects via Bluetooth to a smartphone app, providing immediate results and helps users optimize their diet using long-standing clinical technology but in a handheld, personal device.
The portable nature of AIRE enables the user to collect large amounts of useful data from the comfort of their own home. Digital Health and data collection has the power to guide the doctor’s diagnosis, treatment, and ongoing management of a patient’s health.
SIBO is a very common disorder where there are excessive bacteria present in the small intestine. Colonic fermentation is a natural part of the digestive process, however, for those with SIBO, these inappropriately placed bacteria start to rapidly ferment the contents of the most recently eaten meal. This results in a range of debilitating symptoms, including bloating, abdominal pain, altered bowel movements and nausea. The true prevalence of SIBO in the general population is largely unknown, with some studies estimating its occurrence in up to 15% of healthy individuals. It is also largely associated with many other common clinical conditions, including irritable bowel syndrome, where 40-80% of IBS patients have SIBO.
Robert Ganz, MD, clinical advisor to FoodMarble, states: “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. AIRE also gives the patient the power to check their response to the antibiotic treatment by repeat testing. Furthermore, SIBO relapse is also very common and can occur within months of the initial clearance of infection. Therefore monitoring with AIRE can us help identify the early signs of relapse before the infection reoccurs .”
The trial compared FoodMarble’s ‘AIRE’ device to the current gold standard Lactulose hydrogen breath testing (LHBT) for the diagnosis of SIBO.
Breath testing is popular due to it being non-invasive and patient-friendly, however, it’s often a standalone test carried out in a clinic over many hours. The reported accuracy for this test varies, mainly due to differences in the testing protocols and the interpretation of results. Therefore, the overall accuracy of LHBT for SIBO diagnosis has been questioned, especially based on a one-time snapshot test, using an artificial substrate (e.g. lactulose) to diagnose SIBO. However, by measuring a patient’s post-prandial hydrogen response to their regular diet or meals, and assessing how their symptom changes over time, may provide useful insights and potentially address some of the limitations of the current LHBT.
30 patients suspected of SIBO and 14 healthy subjects, recorded baseline and post-prandial hydrogen breath and symptoms (bloating, abdominal pain) in response to their morning and evening meals using the AIRE device and app. A LHBT was also performed using AIRE and compared against a commercially available mail-in, LHBT kit using concordance analysis.
Results
The AIRE test was shown to exceed the performance of the mail-in LHBT kit and was deemed to be superior. The AIRE test was positive in every instance that the mail-in LHBT test was positive, however, AIRE also picked up two additional positive cases which the mail-in LHBT kit did not.
There was a strong positive linear correlation (r =0.96) between the AIRE test and the mail-in LHBT kit. Furthermore, AIRE enables the real-time measurement of breath Hydrogen, which is beneficial because Hydrogen is highly diffusive and has a tendency to leak out of sample collection bags.
It was also concluded the AIRE device enables real-time meal-related breath testing and symptom logging and the direct and immediate measurement of breath samples is recommended.
FoodMarble Co-Founder & CEO, Aonghus Shortt, adds: “We have witnessed a clamour for greater access to SIBO testing from those who suspect that they may be affected. This has translated into growing interest from gastroenterologists, especially during a time when they often cannot see their patients in person and must rely on telehealth and remote monitoring. We strongly believe that tracking the response to multiple meals over several days, instead of a single-snapshot test, can better reflect typical digestive processes and support better diagnosis. To see our technology clinical validated is extremely satisfying. We will continue to develop and help validate new tools for clinicians, which will ultimately help patients overcome debilitating and harmful conditions.”