CHARM Study
Research type
Research Study
Full title
The CHARM Study: CHARacterizing the Microbiome of Crohns Disease Fistulae
IRAS ID
273526
Contact name
Richard Brady
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
39996, ISRCTN SUBMISSION NUMBER
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Finding the best strategy for managing perianal Crohns Disease (CD) fistula is seen as one of the highest priority non-cancer related questions and is recognised as a poorly understood and debilitating condition. A fistula is a small tunnel that develops between the end of the bowel and the skin near the anus (where poo leaves the body). They result from an infection near the anus causing a collection of pus in the nearby tissue. When the pus drains away it can leave a small channel behind. There is evidence that bacteria in the fistula tract may be different in patients with CD compared to those without CD. This suggests that there could be a different way to identify and treat this condition.
We will look in detail at the bacterial composition of samples from the tracts of patients with fistulae taken during surgery. Those patients with CD fistulae will have their samples compared with those obtained from non-CD fistula patients.
We aim to use technology to create a detailed map of the type of bacteria involved in CD related fistula and find out whether this is different to bacteria in other types of fistula. This may allow us to identify CD fistula earlier, better understand how they happen and identify new targets for potential treatment in the future.
We are looking at a small group of patients initially prior to undertaking a much larger national study if significant patterns emerge.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
21/SW/0110
Date of REC Opinion
10 Nov 2021
REC opinion
Further Information Favourable Opinion