Human gas capsule clinical trial study on healthy volunteers

The day before commencing the formal clinical trial, three standardised meals will be provided to the participant. The following day the investigators will then provide the participants thecapsule to swallow with a standardised meal and a specific carbohydrate syrup drink. The two groups will be split into absorbable carbohydrate syrup (glucose) and fermentable carbohydrate syrup (inulin). A range of quantities from 1.25 g to 40 g mixed in 200 mL of water will be tested on smaller subsets within the two groups. An external data acquisition system will also be provided and attached around the participant’s waist for most of the time after the capsule intake. This is a small handheld receiver that receives the transmission from the capsule, strores the data locally on a SD card and is Bluetooth linked to a smart phone. The smart phone will be provided to display the GI gas data and temperature in real-time. Subsequently, the investigators will measure and record participants’ temperature, heart rate, blood pressure and exhaled gas concentration by blowing into a breath analyser, which will provide necessary data for analysis. Afterward, the investigators will transport the participants to the appointed hotel. The hotel is at least 3 and half star to assure their comfort. The participants can socialise with each other and have a relaxed and enjoyable time in the hotel with low key physical activities, such as walking, eating, reading, watching TV and so on. The participant will need to collect his/her stool sample with the provided flushable faecal collection sheet and container, and provide it to the investigators to check if the capsule has been excreted. The investigators assess the microbial communities that may colonise on the surface of the excreted capsule using conventional sequencing methods such as 16S rRNA. The investigators will be on site but make regular visits to the participants to check their health condition and measure their body temperature, heart rate, blood pressure and exhaled gas concentration. The participant will need to stay in the hotel for two days during the formal clinical trial. All the food and drink will be provided by the investigators to ensure the consistence of diet. human gas capsule: Capsule components: the main components of the human gas capsules are similar to the components of the commercial camera and pH capsules in the market. The difference is that the pH sensor or camera is replaced by gas sensors and gas permeable membranes. The main components include: safe and low current silver oxide batteries, electronic boards, gas sensors, gas permeable membranes and the bio compatible shell of the capsule.