MAP infection in Crohns disease and healthy controls (V1)
Research type
Research Study
Full title
Study of MAP infection in healthy people and people with Crohn’s disease
IRAS ID
230528
Contact name
Jeremy Sanderson
Contact email
Sponsor organisation
Guy's & St Thomas' Foundation NHS Trust
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
We are looking to measure what proportion of healthy people in the UK are carriers of a bacterium called MAP (Mycobacterium avium subspecies paratuberculosis).
MAP infects farm animals and is the cause of ‘Johne’s disease’, an animal form of Inflammatory Bowel Disease (IBD) with similarities to Crohn’s disease. People are widely exposed to MAP in the food chain and contaminated water supplies.
The disease we are studying is Crohn’s disease (CD). No cause is recognised and it has become a major healthcare problem. MAP is a candidate in the causation of CD but it is unknown currently what proportion of healthy people in the UK are carriers of MAP compared with people with CD.
A problem has been the absence of a simple, accurate test for MAP infection in humans. We have developed a test using 4 new antibodies uniquely specific for MAP. This study will use a technique called Polymerase Chain Reaction (PCR) – a technique for DNA analysis, and flow cytometry to detect and quantify MAP in blood. It will also use a technique called immunofluorescence microscopy to identify MAP in human gut tissues.
In this study, we wish to recruit 60 participants: 30 healthy people and 30 people with CD.
The aim is to determine what percentage of healthy participants are infected with MAP and compare levels and features of MAP in blood and gut biopsies in healthy people with that in patients with Crohn’s disease.
CD participants will be recruited from those attending GSTT Gastroenterology clinics and endoscopy units. Healthy controls will be recruited from patients attending endoscopy for non-IBD implications.
The study will last 12 months. Participants will have 10ml blood taken for MAP testing. In addition, participants having endoscopy as part of their clinical care will have up to 6 additional gut biopsies obtained for MAP testing.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0651
Date of REC Opinion
3 Dec 2018
REC opinion
Favourable Opinion