Gastrointestinal Function Testing in Cystic Fibrosis V1.0
Research type
Research Study
Full title
A Case-Control, Observational Study of the Postprandial Changes in Magnetic Resonance Imaging Parameters of Gastrointestinal Function in People with Cystic Fibrosis
IRAS ID
247028
Contact name
Alan Smyth
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
People with cystic fibrosis (CF) have problems digesting their food properly. Not enough is known yet about how digestion is different in people with CF. Finding out more is the first step in developing new medicine to help them improve. Magnetic resonance imaging (MRI) scans allow us to see inside the abdomen. Scans are not painful or harmful and are therefore ideal for repeated measurements, including in pediatric participants. By scanning participants both before and after eating we can see exactly how digestion is working.
We are inviting 40 people who are 12-40 years old, 20 who have CF and 20 healthy people, so we can compare the images. Participants will come in for one day of scanning. We will take a total of 11 scans, starting with eight half-hourly scans followed by three hourly scans. Participants will also fill in symptom questionnaires at every scan, for example if they feel bloated or have any abdominal pain. Each scan will take about 15 minutes and will require short breath holds. Participants will be able to get out of the scanner at any time point if they feel the need to.
Participants will arrive fasted in the morning and will receive a meal right after the first scan and again later in the day. Participants with CF will take their usual medication except for anti-diarrhoeals and laxatives, which have direct influence on digestion.
Our primary outcome is orocaecal transit time, which we hypothesise to be longer in people with CF. Other outcomes include gastric volume, small bowel water content, colonic volume, and water and fat content of colonic chyme.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
18/WM/0242
Date of REC Opinion
20 Aug 2018
REC opinion
Further Information Favourable Opinion