THE CS3M STUDY
CS3M - Crohn's Disease Insights
Crohn’s disease (CD) is a chronic gastrointestinal condition with serious health implications. CD is characterised by the presence of small and large bowel inflammation, alongside an array of extraintestinal manifestations. Intestinal inflammation may cause pain and if left untreated can lead to intestinal ‘perforation’. Chronic, uncontrolled inflammation may lead to weight loss, immune suppression, fatigue, intra-abdominal infection, and can directly cause life threatening sequelae.
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. It is also not clear how to best treat patients with strictures. This pilot study will give novel insights into this area of investigation.
A PILOT STUDY INTO MOTILITY, MICROBIOMICS & METABOLOMICS IN CROHN’S DISEASE
A Bit of Background
Each Crohn’s patient in the study will have a stricture previously identified either endoscopically or with imaging. 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 respective risk profiles will be presented to patients. Should the patient choose to undergo stenting, they will then be asked to take part in the study.
This study will investigate four separate aspects of intestinal strictures in Crohn’s disease:
How stenting of strictures affects the movement of the bowel (a.k.a. motility).
How stenting of strictures affects the bacterial content of the gut (a.k.a. microbiome).
How stenting of the strictures affects bacterial by-products from the gut (a.k.a. metabolomics).
The clinical impact of CD stricture stenting.
Each patient will undergo a Magnetic Resonance (MR) scan 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 techniques used for stool analysis will include bacterial genetic analysis and gas-chromatography analysis of bacterial metabolites. Each patient’s clinical progress will be reviewed and assessed with validated Inflammatory Bowel Disease (IBD) scoring tools.
STUDY SYNOPSIS
Study Objective - The primary aim is to characterise the effect of the stenting of Crohn’s ileocolonic (IC) strictures on gut motility, microbiomics and metabolomics.
Study Configuration - Single centre, prospective cohort study.
Principal Investigators
Dr. Andrew Cole
Assistant Clinical Director / Consultant Gastroenterologist
Royal Derby Hospital
Uttoxeter Road, DE223NE, Derby
Mr. Jonathan Lund
Associate Professor & Consultant Surgeon
University of Nottingham - Health Sciences Department
Royal Derby Hospital
Uttoxeter Road, DE223NE, Derby
ACTIVITIES
Characterising the Effects of Relieving Stricture Obstruction by Ileocolonic Stenting - A Pilot Study into Motility, Microbiomics & Metabolomics in Crohn’s Disease is in the business of changing and shaping lives. The work we do at our Nonprofit Organization is aimed at providing a holistic approach to solving some of our society’s biggest challenges. We make sure our partners are empowered by creating opportunities for individuals and communities.
ROYAL DERBY HOSPITAL
All study activities will be conducted at Royal Derby Hospital.
Royal Derby Hospital
Tel: 01332 340131 Fax: 01332 785566
Address: Royal Derby Hospital
Derby, Derbyshire, DE22 3NE.
UNIVERSITY OF NOTTINGHAM
The CS3M Study is being sponsored by the University of Nottingham.
Research and Innovation
University of Nottingham
East Atrium - Jubilee Conference Centre
Triumph Road, Nottingham, NG8 1DH
Email: sponsor@nottingham.ac.uk
For Further Information Contact:
IBD Research Fellow
Dr. Ronit Das
Research Fellow - IBD
Royal Derby Hospital
Uttoexeter Road, DE223NE, Derby
ronit.das@nhs.net / ronit.das@nottingham.ac.uk
