MRI: Fluid volumes and localisation in paediatric GI tract
Research type
Research Study
Full title
Measurement of fluid volumes and localisation within the gastrointestinal tract of paediatric populations using MRI data
IRAS ID
237159
Contact name
Hannah Katharine Batchelor
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Most drugs are taken orally, as liquids, tablets or capsules. However, designing pharmaceutical products in such a way that the active ingredient is absorbed at an appropriate rate and extent following oral administration is complicated, particularly for paediatric patients.
Current laboratory tests do not mimic accurately the highly variable and dynamic environment of the human intestines, and so their ability to predict the performance of an orally-administered drug in the human body is limited. As a result, researchers rely heavily on tests in animals and clinical studies in humans to verify drug performance, rendering the entire process rather lengthy, expensive and put a high burden on children who participate in clinical studies. There is therefore an urgent need for improved tools to predict the performance of orally-administered drugs; this has been recognised by industry experts as well as regulatory agencies.
Previous work has investigated the volumes of fluid in the stomach and intestine of adults to better understand the implications for drug absorption however there are no studies that have captured this data in paediatric populations.
Critical to the prediction of the absorption of drugs in children is knowledge of the physical environment within the paediatric intestinal tract which underpins a mechanistic understanding of drug product performance: the creation of this knowledge and its application is essential to build relevant physical and in silico models to minimise the burden of clinical trials in children.
This project seeks to enhance the current knowledge of fluid localization within GI tract of paediatric patients, with a particular focus on those aged under 12 years.
MRI images available from routine clinical procedures that capture the stomach and small intestine of children contain sufficient information to quantify both the volume and location of fluid within the gastrointestinal tract of children. This study seeks to gain access to these images to enable measurement of these values.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0251
Date of REC Opinion
22 Aug 2018
REC opinion
Further Information Favourable Opinion