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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Noninfective enteritis and colitisOther diseases of intestines
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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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
The patient will be excluded from the study if any of the following apply: • Patient is aged < 16. • Patient is unable to consent to the study. • If the patient has known IBD and a faecal calprotectin is being requested for disease monitoring purposes. • Where a diagnosis of IBD or IBS is not being considered by the requestor of the test.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by IMPERIAL COLLEGE HEALTHCARE NHS TRUST and funded by NIHR Applied Research Collaboration Northwest London .
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for Trial ID: CPMS 55077
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