A 'magic' new medical device for MRI assessment of gut transit in children with constipation.
14% of young people suffer from constipation during their childhood. Constipation becomes chronic in 30% of them, affecting them and their parents or carers.
Management of these children is difficult and based mostly on symptom reports. An objective measure of the time that food takes to travel through the gut (the ‘gut transit time’) could help doctors make a more informed, early selection of therapy. This could speed up treatment success, improve children and parents’ satisfaction and potentially save the NHS money.
An existing method to measure gut transit time involves ingesting plastic pellets and taking X-ray images to see how much time it takes for the pellets to travel through the gut. However, X-ray images are unable to reveal the colon anatomy well and provide a harmful radiation dose, so the method is not very effective.
Our ‘magic’ new medical device
Dr Luca Marciani and his team of scientists, doctors, young people, parents and medical technology companies designed a new medical device aimed at measuring gut transit time using magnetic resonance imaging (MRI). MRI has better image quality than X-rays and uses no harmful radiation.
We created new, small plastic capsules filled with liquid that can be seen by MRI. The capsules are only a few millimetres long, easy for young people to swallow. They do not dissolve in the body but travel along the gut, where they can be imaged using just a quick MRI scan.
We have carried out a first-in-child feasibility clinical study of the mini-capsules in 35 young persons with and without constipation. We called the study ‘MAGIC’ for MAGnetic resonance Imaging in paediatric constipation.
We confirmed that the mini-capsules can be swallowed easily by young people and can be successfully imaged in the gut using MRI, thereby proving a measure of whole gut transit time.
Our young people group was involved directly with the professionals to design and produce the mini-capsules, the test kit packaging and all the recruitment materials.
The next phase of this work has already started. We are working with our young people and adult involvement groups and three companies to:
- Develop new methods to manufacture the mini-capsules, faster and cost-effective, so that the mini-capsules will be made on an industrial scale and distributed worldwide.
- Carry out a multi-centre clinical trial in constipated young patients, recruited from eight hospitals in the UK. We will show that using the mini-capsules can improve treatment success informing early choice of therapy.
- Develop computer software that can detect the mini-capsules semi-automatically and produce reports of the gut transit time test.
Funding and intellectual property
This work is funded by two NIHR Invention for Innovation (i4i) awards and has already generated two patents.