None listed
Conditions
Brief summary
When swallowed, the Atmo gas capsule consists of several gas and temperature sensors which provides information on oxygen concentrations, and therefore, passage of the capsule between aerobic (small intestine) and anaerobic regions (large intestine). That way, regional transit measurements can be accurately derived. To validate this device, simultaneous ingestion of this and an existing device measuring pH (SmartPill) to determine time comparison of gut transit will be conducted to show equivalence of the two devices in transit measurements.
Interventions
The study will involve simultaneous ingestion of two medical devices - the Atmo gas capsule and the SmartPill capsule. This will be completed only once.
Following an overnight fast (water only for at least 8 hours), participants will attend the Department of Gastroenterology, Alfred Hospital where a simultaneous transit study with the SmartPill capsule will be performed with the gas-sensing capsule. Participants will first be asked to be consume a cereal bar with 200 mL water within a 5 min
The study will involve simultaneous ingestion of two medical devices - the Atmo gas capsule and the SmartPill capsule. This will be completed only once. Following an overnight fast (water only for at least 8 hours), participants will attend the Department of Gastroenterology, Alfred Hospital where a simultaneous transit study with the SmartPill capsule will be performed with the gas-sensing capsule. Participants will first be asked to be consume a cereal bar with 200 mL water within a 5 min timeframe, followed immediately by ingestion of both the SmartPill and Atmo gas capsule, simultaneously. They will fast for the next 6 hours, then consume their normal meals for the rest of the day. Once the Atmo capsule is swallowed, it transmits information about individual gases (hydrogen, carbon dioxide, methane and oxygen) and temperature every 5 minutes to an external receiver worn around the participant's waist. The SmartPill capsule on the other hand, transmits information every 20 seconds regarding pH, pressure and temperature to an external recorder. Data recording will then be ceased once the capsule has been passed (confirmed visually in the toilet bowl or signal loss from both capsules after a bowel movement) from the body. Both the Atmo gas capsule and SmartPill device are simple, safe and non-invasive methods for learning about the inside of the bowel without the necessity of putting tubes into the bowel.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers without known gastrointestinal conditions
Exclusion criteria
Pregnancy, body mass index >27 kg/m2, previous abdominal surgery, history of gastrointestinal,endocrine or neurogenic disorders known to influence gastrointestinal motility (including Crohn's disease, diverticulosis, bowel obstruction), swallowing difficulties, receiving diathermy, implantable devices such as a pacemaker, antibiotic, pre-, probiotic use in the last 4 weeks, radiation enteritis, gastric bezoar, suspected or known strictures and current participation in other trials.
Outcome results
None listed