Irish digital digestive health start-up FoodMarble has completed a clinical trial that investigates the use of its Aire device in diagnosing a digestive condition marked by bacterial overgrowth in the small intestine.
The trial, which was conducted at Johns Hopkins Medicine in the US and led by Prof Jay Pasricha, found the company's remote-monitoring Aire device exceeded the gold standard testing for small intestinal bacterial overgrowth (Sibo), a condition that can lead to bloating, abdominal pain, altered bowel movements and nausea.
As part of the trial. FoodMarble’s Aire device to Lactulose hydrogen breath testing (LHBT), which is considered the current gold standard for the diagnosis of Sibo.
The trial included 30 patients suspected of Sibo and 14 healthy subjects. It recorded baseline and post-meal hydrogen breath and symptoms such as bloating and abdominal pain using the Aire device and app. It also compared LHBT using Aire, and a commercially available postal LHBT kit.
The trial deemed the Aire test was superior to the LHBT mail-in kit, recording a positive result in every instance that the mail-in LHBT did, and also picking up two cases that the mail-in kit did not.
The trial also found the FoodMarble device had the potential to overcome other shortcomings of standard Sibo breath testing. Because Aire also allows for the real-time measurement of breath hydrogen, it was considered beneficial as mail-in methods relied on sample collection bags, which were at risk of leaking hydrogen.
"The Covid pandemic has emphasised 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," said FoodMarble's clinical adviser Robert Ganz.
“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 the signs of relapse before the infection reoccurs .”
Co-founder and chief executive Aonghus Shortt said Aire was originally developed due to his wife Grace's experience with irritable bowel syndrome (IBS).
However, the growing focus on Sibo in recent months led to exploring whether the device could do as well as more traditional diagnosis methods.
“On the consumer side, the focus has been around helping identify food triggers for people to guide them through adapting their diet, with a focus around IBS. But on the clinical side there has been a big demand, which we were feeling from the start,” he said, noting the expense of the antibiotics used to treat Sibo. “It’s a big gap in the market. Insurers and the government don’t want to pay for expensive drugs. If more doctors had the equipment to test for Sibo, and if it was possible to test in the home, it becomes a very accessible tool to rule in or rule out the condition. That’s the goal.”
Aire targets people with food intolerances, helping them control the issue by identifying specific foods that could be triggering symptoms of conditions such as IBS.
Clinical breath analysis tests can be carried out to diagnose these issues, but are typically hospital based with expensive equipment, and may not always capture how the patient reacts to certain foods. More than 25,000 people have now used the Aire device.
The trial is still ongoing in the US, but Mr Shortt said the potential market in the US alone was significant.
According to FoodMarble, about one in eight people globally are affected by digestive problems. That includes IBS and and food intolerances to common food items and ingredients such as lactose, wheat, fructose and others.
“Around $134 billion [€114 billion] was spent on gastrenterology in 2018. You can see the numbers are huge. In a lot of cases, you are bringing people through procedures almost because as a clinician you don’t have something they can do otherwise,” he said.
“If we can get in the middle there as something that is not as expensive, is convenient for patients, gets them to where they need to get to in terms of understanding what the problem is, that’s a bit win for everyone.”