Investigating fibrosis activity in Crohn’s disease (FATE CD)

• Research type

  Research Study

• Full title

  A cross-sectional study investigating the role of fibrosis activity in Crohn’s disease

• IRAS ID

  319288

• Contact name

  Rahul Kalla

• Contact email

  rahul.kalla@ed.ac.uk

• Sponsor organisation

  University of Edinburgh

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  3 years, 0 months, 0 days

• Research summary

  Crohn’s Disease (CD) is a chronic inflammatory condition that can affect any part of the intestine and currently has no cure. Recent data suggests that the despite significant progress in treatments over the last 2 decades to help control disease, upto half of patients still develop progressive bowel scarring that require surgery and upto 70% needing surgery within a 10 years from diagnosis. Preservation of a healthy length of small bowel that is free of disease is critical to prevent the long term risk of gut failure and death. Our current treatments focus on resolving inflammation but there are no treatments targeting scarring (fibrosis), its activity and its progression. A major hurdle in our progress towards anti-scarring treatments and advancing care in CD has been our inability to identify bowel scarring accurately; this being critical in developing new treatments that prevent permanent bowel damage.
  The quantification of intestinal fibrosis activity has the ability to advance our understanding of the pathological processes that occur in CD. By improving our understanding of the pattern and timing of fibrosis activity, we may be able to identify early sub-clinical fibrosis and develop future anti-fibrotic therapies that target fibrosis activity and measure clinical trial end-points for novel anti-fibrotic drug therapies. We aim to study fibrosis activity in patients at different stages of their disease, comparing ileal CD to healthy controls and those with UC

  The study population will comprise of 3 groups. Group 1: patients with Crohn's disease with ileum disease. Group 2: healthy volunteers and Group 3: Ulcerative colitis patients. Patients will be approached to take part in the study and once consent has been obtained a mutually convenient time will be organised for the participant to fill in questionnaires for the study, provide blood and stool samples and undergo a PET/MRI scan.

• REC name

  West of Scotland REC 1

• REC reference

  23/WS/0094

• Date of REC Opinion

  13 Jun 2023

• REC opinion

  Unfavourable Opinion