Calprotectin in IBD ORI-CAL-01 v1.0
Research type
Research Study
Full title
Comparison of Calprotectin Levels in Stool and Rectal Mucus in Subjects with Suspected or Confirmed Inflammatory Bowel Disease
IRAS ID
191169
Contact name
John Mclaughlin
Contact email
Sponsor organisation
Origin Sciences Limited
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
Calprotectin is currently measured in stool to support the diagnosis of inflammatory bowel disease (IBD). Calprotectin is also present in rectal mucosa (surface lining of the rectum) and may provide a convenient alternative sample to stool. OriCol™ is a device for taking a sample of rectal mucosa. This study will evaluate whether the level of calprotectin in rectal mucosa can be used in the diagnosis of IBD.
In part 1 of the study, patients with a known diagnosis will have a rectal mucosa sample taken during a proctoscopy examination in order to establish a diagnostic level of calprotectin in rectal mucosa. In part 2, patients with suspected IBD will provide a sample and their rectal calprotectin level will be compared to their eventual diagnosis. A second cohort of patients in Part 2 will be those with known IBD who are being monitored for flare-up episodes.
All patients will also be asked to provide a stool sample to be analysed for the presence of calprotectin as part of their routine care. Part of this sample, and the rectal mucosa samples will then be shipped to the Sponsor for analysis of calprotectin. All patients will also be asked to complete a questionnaire to rate the acceptability, convenience, and experience of both sampling methods.
Patients will follow normal hospital practice for the diagnosis and treatment of IBD. The result of the rectal mucosa calprotectin and the Sponsor stool tests will have no impact on patient care, but will be compared with the patient disease status to see how accurate the test is at detecting IBD.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
15/NW/0821
Date of REC Opinion
15 Dec 2015
REC opinion
Further Information Favourable Opinion