‘The Crohn’s Stricture CS3M Study’ (CS3M)
Research type
Research Study
Full title
Characterising the Effects of Relieving Stricture Obstruction by Ileocolonic Stenting - A Pilot Study into Motility, Microbiomics & Metabolomics in Crohn’s Disease
IRAS ID
252808
Contact name
Angela Shone
Contact email
Sponsor organisation
Research and Innovation - University of Nottingham
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Crohn's Disease (CD) patients frequently experience abdominal pain, nausea, and diarrhoea. These symptoms may result from ‘narrowings’ within the bowel known as ‘strictures'. Crohn’s patients who have intestinal surgery experience ‘stricturing’ (the formation of strictures) more often. The ‘CS3M Crohn’s Stricture Study’ will give new insights into ‘strictures’ in this context. There are many unanswered questions. It is unclear how strictures affect bowel contraction, bacteria within the gut and bacterial by-products.
Each Crohn’s patient in the study will have a previously identified stricture. A number of different treatment modalities exist - including surgical resection, stricturoplasty and endoscopic balloon dilatation. Intestinal ‘stenting’ is one of the available therapies. It involves the endoscopic placement of an opening device, known as a ‘stent’, into the affected area. All modalities and their risk profiles will be presented to patients. Should a patient choose to undergo stent therapy, they will then be invited to take part in the study.
Four separate aspects of intestinal strictures in CD will be investigated:
1. How stenting of strictures affects the movement of the bowel (a.k.a. motility).
2. How stenting of strictures affects the bacterial content of the gut (a.k.a. microbiome).
3. How stenting of the strictures affects bacterial by-products from the gut (a.k.a. metabolomics).
4. The clinical impact of CD stricture stenting.Each patient will undergo a Magnetic Resonance (MR) scan assessing intestinal motility before and after stent treatment. Stool samples will be collected prior to and following stenting. These stool samples will be analysed for bacterial content and by-products. The novel insights into strictures in CD will be delivered by data produced by motility, microbiome, and metabolomic analysis. This research will generate the first global report such findings.
REC name
HSC REC B
REC reference
18/NI/0241
Date of REC Opinion
24 Dec 2018
REC opinion
Further Information Favourable Opinion