Measuring intestinal gases using the Atmo Gas Capsule in patients with inflammatory bowel disease

The Atmo Gas Capsule is a novel swallowed capsule device sponsored by Atmo Biosciences. It is designed to measure the levels of certain gases eg. oxygen, carbon dioxide, hydrogen, methane, as the capsule passes through the bowels. The pattern of gas concentrations will reflect the microbiome composition of the bowels. This is an explorative study in 5 patients with active inflammatory bowel disease. Participants will be patients of at least 18 years old who are to be newly commenced on treatment of their active inflammatory bowel disease. Due to Crohn's disease being associated with an increased risk of intestinal strictures and possible capsule retention within the body, patients with Crohn's disease will need to have had a magnetic resonance enterography (MRE) scan within the past 3-6 months demonstrating no strictures, or first demonstrate the ability to pass a wax capsule containing a radiofrequency identifier. The wax capsule will dissolve and not cause harm even if it fails to pass through the bowels. An externally held radiofrequency detector can be used to see whether the wax capsule remains in the body. If the wax capsule is not passed within 5 days, these patients will not proceed with the remainder of the study. Participants with ulcerative colitis will not need to be first screened using a wax capsule as ulcerative colitis does not predispose patients to intestinal strictures. Participants allowed to proceed with the Atmo Gas Capsule will then fast overnight before presenting to the Department of Gastroenterology at Concord Hospital where they will swallow one Atmo Gas Capsule under supervision, before fasting for a further 6 hours. This will be repeated in 8-12 weeks following treatment of their active inflammatory bowel disease. In each case, once the Atmo Gas Capsule is swallowed, it transmits information about individual gases (hydrogen, carbon dioxide, oxygen and methane) and temperature every 5 minutes to an external receiver connected to a mobile phone device (both provided by Atmo Biosciences). Data recording will then be ceased once the capsule has been passed from the body (confirmed visually in the toilet bowl or signal loss from the capsule after a bowel movement). Participants will need to keep the data receiver for the gas capsule within 1.5 metres of their body until passage of the capsule has been confirmed. The Atmo Gas Capsules are single-use and will not be collected from the toilet bowl. The data are sent to the Cloud and analysed against a pre-trial calibration of the individual capsules. The pre-trial calibration is run in a controlled environment with gas mixtures created using a mass flow controller. From this study we hope to see if and how the pattern of intestinal gas composition will change as the inflammatory bowel disease activity changes, and if the pattern of gas will predict response to treatment of active inflammatory bowel disease. Standard care for treating active inflammatory bowel disease will depend on the participants' gastroenterologist. This might include biologic medications, nutritional interventions, blood tests, scans, or endoscopy. There is no single guideline that will determine the treatment used. In each case, participation in this study will not alter any medical management planned for participants had they not been involved in this study.