Re-appraising the Use of Faecal Calprotectin as a Diagnostic Test
Research type
Research Study
Full title
Re-appraising the Use of Faecal Calprotectin as a Diagnostic Test
IRAS ID
310583
Contact name
Horace Williams
Contact email
Sponsor organisation
Research Governance and Integrity Team (RGIT), Imperial College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Faecal calprotectin (FC) is an established marker of gastrointestinal inflammation. Multiple studies have demonstrated elevated levels in the stool of inflammatory bowel disease (IBD) patients relative to control groups, such as patients with irritable bowel syndrome (IBS). Patients frequently have a FC test performed in primary care before being referred to secondary care for more specialist tests (such as a colonoscopy) if the FC is elevated.
However, there are significant concerns regarding the current use of FC:
1. There is concern about FC levels and stool consistency. Large numbers of patients without diarrhoea, passing stool of normal consistency, have a FC performed and are referred onwards for further investigation if elevated (despite the majority of patients with IBD presenting with diarrhoea). No published studies have investigated the use of FC in this context.
2. Despite its widespread use in primary care, there is little evidence for its use in this setting: the vast majority of initial FC research studies were performed in secondary care.
3. There is also uncertainty regarding what level FC should be considered raised. Some studies suggest that a cut off of 50µg/g, as recommended in the NICE guidelines, results in unnecessary investigation.
This study will prospectively investigate the utility of FC in primary care, with a focus on establishing whether or not it is of value in the absence of diarrhoea. It will also re-evaluate its cut-off value.
Patients for whom a GP feels a FC is indicated will be recruited to the study and the stool consistency of their FC sample recorded by laboratory staff. They will then be followed up over a one year period to ascertain their clinical outcome. This will allow the diagnostic accuracy of FC to be calculated in the context of diarrhoeal and non-diarrhoeal stool. An appropriate cut-off value can also then be calculated.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
23/NW/0034
Date of REC Opinion
27 Jan 2023
REC opinion
Further Information Favourable Opinion