Improving fecal sample collection in patients with inflammatory bowel disease: A comparative evaluation of two calprotectin devices.

Background: Fecal calprotectin (FC) is a non-invasive biomarker that can be used to guide treatment decisions in inflammatory bowel diseases (IBD). Low compliance may hinder routine testing, with stool collection being the primary obstacle.

Aims: The objective was to compare an alternative collection device (sampling bottle) to a conventional container for stool sampling in terms of acceptability and compliance with FC testing in patients with IBD.

Methods: In this prospective study, patients were randomly assigned 1:1 to either the standard laboratory method (Bühlmann fCAL® turbo) or the ProciseFCP™ assay. Acceptability was assessed using qualitative and quantitative scales. Factors associated with FC acceptability, and compliance with FC testing, were analyzed. Only the stool sampling procedure was evaluated, not the satisfaction with the 'point-of-care' assay.

Results: In total, 156 patients were included. The ProciseFCP™ device was associated with higher acceptability than the standard container on the ordinal scale (primary outcome) (OR 2.69, p < 0.001). Using the visual analog scale (secondary outcome), a positive difference of 30.0 % (95 % CI: 19.7 to 44.7) was found in favor of the ProciseFCP™ arm, but this was not statistically significant (CI including the predefined threshold of a 30-point difference). Compliance was similar and high in both groups (80 %).

Conclusion: This study demonstrates that a sampling bottle offers a patient-friendly alternative to the conventional stool container, significantly enhancing patient's acceptability with stool collection. These findings support the integration of patient-centric innovations in diagnostic testing to improve the monitoring and management of IBD.