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Table 1 The MAGIC Study and The TransiCap™ Medical Device

From: “A little (PPI) MAGIC can take you a long way” : involving children and young people in research from inception of a novel medical device to multi-centre clinical trial Roald Dahl, James and the Giant Peach (1961)

The clinical background of the MAGIC study is paediatric constipation and the project was funded by a NIHR Invention for Innovation (i4i) Product Development Award grant. Constipation in children is a common and often distressing problem and is termed functional constipation when no underlying cause can be detected. Functional constipation prevalence worldwide is estimated between 4 and 36%, with 34% of children in Britain aged 4–11 years reported to have had constipation. The cost to the healthcare system is high, at ~$3.9 billion/year [2,3,4,5,6,7,8].
Management of these children is difficult and based mostly on symptom reports [9, 10]. The existing method to measure gut transit time (the time it takes for food to move through the gut) involves ingesting plastic pellets and taking X-ray images [11]. However, X-ray images are unable to reveal the colon anatomy well and provide a harmful radiation dose. The research team sought to find a modern alternative to the old X-ray method by designing a similar method of measuring gut transit time but using magnetic resonance imaging (MRI). MRI has better image quality than X-rays and uses no harmful radiation and is therefore the preferred choice when imaging children.
In this project the research team designed and manufactured new, small plastic capsules filled with liquid that can be seen by MRI. The capsules are only a few millimetres long and are easy for young people to swallow. They do not dissolve in the body but travel along the gut, where they can be imaged using a quick MRI scan. The TransiCap™ mini-capsules (now patented and trademarked) are a medical device manufactured by JEB Technologies Ltd. (UK).
The team obtained all necessary Ethics and regulatory approvals and ran a ‘first-in-child’ feasibility clinical study of the mini-capsules in young patients with constipation and healthy controls. The study recruited 35 children between 7 and 18 years old. On day 1, 2 and 3 of the study the participants swallowed 24 mini-capsules and on day 4, 7 and 28 they had a quick 15 min MRI scan to locate the position of the mini-capsules. We confirmed that the mini-capsules can be swallowed easily by 35 young people and successfully imaged in the gut using MRI to determine their gut transit time.
The research team were then successful in obtaining a second NIHR i4i grant award for the follow-on work, MAGIC2. MAGIC2 is a large multi-centre clinical trial across 8 hospitals in the UK recruiting 436 young constipated patients to assess if using the mini-capsules MRI gut transit time test can improve treatment success. Participants will be asked to swallow 24 mini-capsules each day for 3 days and then have an MRI scan on days 4 and 7. All participants will be randomly assigned to two groups. An intervention group will receive their gut transit time results immediately after the day 7 MRI scan; the results will thus be available to guide treatment selection. A control group will also have the day 7 MRI scan but the results will not be shared with their care team until the end of the trial; their treatment selection will not be guided by the MRI results. The results will only be delayed so that a proper comparison with the intervention group can be made. Computer software that can detect the mini-capsules semi-automatically will also be designed.