PaedGIFT (Paediatric Gastro-Intestinal Fluid and Tissue)
Research type
Research Study
Full title
Characterisation of fluids and mucosal tissues from paediatric stomach and small intestinal tract to enable development of biorelevant models to predict drug absorption
IRAS ID
251909
Contact name
Hannah Batchelor
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
Understanding the conditions in the stomach and intestine of children is important in predicting how medicines work once they are swallowed. The composition of the fluids present will dictate how much of the drug dissolves, and how quickly this may happen. Only dissolved drug can be absorbed and have its effect so it is important to understand this process. In addition there are many transporters in the intestine that act as gates for drugs and dictate how much will be absorbed.
Currently we know about the fluids and transporters in adults but we do not know how different the conditions are in children. This study seeks to access samples from childrens' intestines to characterise the fluids and the transporter expression to compare these results to data that exists in adult populations.
We plan to collect samples for our research with the minimum burden to children. During endoscopy fluid is removed to allow the doctor to have a better look at the intestines; usually this fluid is discarded. We will ask permission to collect and use this fluid for characterisation. We will also ask for additional consent for biopsies to be taken during the endoscopy that will be used to quantify drug transporter expression. Some children require an enterostomy to remove a stoma and rejoin the ends of their intestine; during this surgical procedure a small amount of intestinal tissue is discarded and we will ask consent to collect this tissue and use it to quantify drug transporter expression. We will also ask for additional consent to take a fluid sample from the stoma for characterisation.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
18/WM/0390
Date of REC Opinion
4 Feb 2019
REC opinion
Further Information Favourable Opinion