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. |