GIFT-CF 3 V1.0
Research type
Research Study
Full title
Gut Imaging for Function & Transit in CF – GIFT-CF 3: evaluation of triple combination therapy.
IRAS ID
281133
Contact name
Alan Smyth
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Between 65% and 100% of people with cystic fibrosis (CF) experience gut symptoms and it is a top priority for patients, their carers and health care professionals to understand how to relieve the symptoms. More than 8 in 10 patients must take medication to assist with their digestion but complications such as bowel blockage still occur. Limited evidence exists to understand the mechanisms of CF gut disease.
MRI data from the first GIFT-CF study has shown there to be statistically significant differences between healthy volunteers and people with CF for oro-caecal transit times, colonic volume and small bowel water content.
Kaftrio is the newest CF drug which aims to correct the underlying defect in CF. Kaftrio has just been licensed by EMA and UK patients will be commencing this treatment, for the first time, over the next few months
We will invite 12 people with CF homozygous for p.Phe508del (approximately 49% of our clinic in this category) and 12 people with CF who are compound heterozygotes for p.Phe508del and a minimal function mutation (approximately 41% of our clinic in this category) to attend 3 study days (before they start Kaftrio, at 12 weeks and 24 weeks) at the Sir Peter Mansfield Imaging Centre.
On each study day, participants will undergo MRI scans before and after 2 standardised meals. They will undergo a total of 11 MRI scans, each lasting about 15 minutes and requiring short breath holds.
Our primary outcome is the oro-caecal transit time, defined as the time when the test meal is first detected in the caecum. The secondary outcomes will include: small bowel water content and colonic volume (area under the curve corrected for body surface area); change in small bowel water content between 240 and 300 minutes; stool calprotectin; sputum and stool microbiome;terminal ileum motility; abdominal symptoms; spirometry.
REC name
London - Chelsea Research Ethics Committee
REC reference
20/PR/0508
Date of REC Opinion
21 Oct 2020
REC opinion
Further Information Favourable Opinion