Improving Faecal Calprotectin Test Accuracy
Research type
Research Study
Full title
Improving Faecal Calprotectin Testing Accuracy for Better Monitoring and Treatment of Inflammatory Bowel Disease
IRAS ID
359943
Contact name
Craig Mowat
Contact email
Sponsor organisation
University of Dundee
Duration of Study in the UK
0 years, 5 months, 4 days
Research summary
This study focuses on a stool test called faecal calprotectin (FC), which is commonly used to monitor inflammation in the bowel. Raised FC is an important sign of active inflammatory bowel disease (IBD), such as Crohn’s disease or ulcerative colitis. Patients collect a small stool sample at home, which is analysed in the laboratory. Doctors use the FC result to decide whether the condition is well controlled (usually a result below 250 micrograms per gram) or whether treatment needs to be increased to reduce the risk of flare-ups.
Recently, NHS Tayside introduced a new stool collection device (the BÜHLMANN CALEX® system). Since this change, there have been concerns that results from this new device are higher than those obtained using the traditional plain stool pot. If results are affected by the type of collection device used, this could influence treatment decisions for patients.
This study has two main parts. First, patients with IBD will be asked to provide a single stool sample and place portions of it into both a traditional stool pot and the new CALEX® device. The FC results from each method will be compared to see whether the collection device changes the test result and whether this could alter clinical decisions.
Second, we will review laboratory records for FC results below 250 micrograms per gram before and after the new device was introduced. These results will be linked to patients’ health records to see how many went on to experience a disease flare within the following year.
The results of this study will help determine whether the choice of stool collection device affects FC accuracy. This could improve how doctors interpret FC results, leading to better treatment decisions, fewer unnecessary medication changes or hospital visits, and more personalised care for people living with IBD.REC name
West of Scotland REC 5
REC reference
26/WS/0073
Date of REC Opinion
2 Jun 2026
REC opinion
Further Information Favourable Opinion