None listed
Conditions
Brief summary
The invention of an ingestible gas-sensing capsule promises a world of possibilities in research understanding of the activities of the gut bacteria in response to food. This technology, named the ATMO capsule, is capable of detecting changes in multiple gas concentrations (oxygen, carbon dioxide, hydrogen and methane) as a result of bacterial breakdown of food components (e.g. fibre) as it travels through different parts of the digestive tract. The completion of Phase 1 clinical studies in 23 healthy controls have proven its safety and functionality. Further studies are now needed to explore the utility of this technology in a clinical setting, such as in the assessment of regional transit times. If these studies are successful, this will mean the availability of a technology that is low cost, non-invasive and potentially usable as a point-of-care testing for individuals with gut conditions. A particularly attractive feature of the ATMO capsule is its ability to distinguish the small (aerobic region) vs large intestine (anaerobic region) via changes in oxygen concentrations. A step-wise decrease in oxygen levels have also been proposed as landmarks for distinguishing movement from the stomach to the small intestine. However, these anatomical landmarks remain theoretical and require further validation. A study utilising a similar ingestible capsule (the SmartPill capsule) is already underway to achieve this goal but preliminary results from this study require validation via an non-invasive imaging technique - gastrointestinal ultrasound. We have previously had good success in locating the ATMO capsule in one healthy volunteer but further data are needed to visualise the ATMO capsule within two key proposed anatomical positions (stomach to duodenum; ileum to caecum) in order to provide a way of validating gas profile landmarks. We hypothesised that changes in oxygen-equivalent and hydrogen concentrations as measured by the gas capsule provide identification of key anatomical landmarks within the gastrointestinal tract. The aim of the study was to develop and validate markers of anatomical landmarks of the ATMO gas capsule using gastrointestinal ultrasound in healthy controls.
Interventions
The study will involve ingestion of a wireless, gas-sensing (Atmo) capsule with simultaneous gastrointestinal ultrasound (GIUS) imaging to validate the localisation of the Atmo capsule. This study will occur once.
Following an overnight fast, the subjects will arrive at the Department of Gastroenterology, Alfred Hospital for the study. A baseline gastrointestinal ultrasound (GIUS) will be performed by an experienced GIUS-trained gastroenterologist to assess the participant's basic abdominal an
The study will involve ingestion of a wireless, gas-sensing (Atmo) capsule with simultaneous gastrointestinal ultrasound (GIUS) imaging to validate the localisation of the Atmo capsule. This study will occur once. Following an overnight fast, the subjects will arrive at the Department of Gastroenterology, Alfred Hospital for the study. A baseline gastrointestinal ultrasound (GIUS) will be performed by an experienced GIUS-trained gastroenterologist to assess the participant's basic abdominal anatomy (the participant will be consenting and fully awake and be able to see the scan in real-time). The images from this scan are not recorded. Following ingestion of the Atmo capsule, dynamic scanning using GIUS will commence following the transit of the capsule through the stomach and small intestine. Ultrasound images of the capsule passing through the pylorus (stomach) and ileocaecal junction will be taken. Images of these landmarks will record time and proof of capsule transit. Data will be collected in a coded manner. Ultrasound imaging will cease once arrival of the capsule in the large intestine has been confirmed. Additionally, once the ultrasound imaging has been completed, participants will be allowed to leave the facility. Instructions on confirming passage of capsule during a bowel movement will be provided. It is anticipated that the Atmo capsule will take approximately 24-48 h to pass through the gastorintestinal system. Participants will also be instructed to keep the Atmo receiver close to their body (within 1.5 m) at all times.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy controls without known gastrointestinal disease/disorder
Exclusion criteria
history of gastrointestinal, endocrine or neurological disorders known to influence gastrointestinal motility, dysphagia, presence of suspected strictures, radiation enteritis or gastric bezoar; pregnancy; individuals with a body mass index >30 kg/m2, those with previous abdominal surgery (except appendicectomy) or implantable devices such as a pacemaker; antibiotic, prebiotic or probiotic use in the last 4 weeks; intake of proton pump inhibitors, H2 receptor antagonists, antacids in the last 7 days or prokinetics in the last 2 days; those who are currently receiving diathermy or have planned MRI or diathermy in the next 2 months.
Outcome results
None listed