Clinical trial NCT01676324: FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of Inflammatory Bowel Disease (IBD)
Official title: FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of IBD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Keywords: Fecal Calprotectin
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 289
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be those age 19 or older seen by community and academic gastroenterologists and may be referred for Fecal Calprotectin testing at the discretion of the Gastroenterologist.

Brief summary: Hypothesis:

Fecal Calprotectin will be useful in guiding the diagnosis and management of patients with Inflammatory Bowel Disease. Fecal Calprotectin can be utilized as an alternative to colonoscopy in the management of patients with Inflammatory Bowel Disease.

Objectives:

By means of a survey from the ordering physician we would assess:

Primary Endpoint

1. The Percentage of time that the Fecal Calprotectin result caused the physician to change the management of a patient.

Secondary Endpoints

1. To determine if the Fecal Calprotectin result influenced the number of endoscopies performed
2. To correlate how well the Fecal Calprotectin correlates with Endoscopic findings when endoscopy was performed.
3. To assess the correlation between the Fecal Calprotectin level and symptoms as measured by the Harvey Bradshaw index or the partial Mayo Score (or full Mayo Score depending if endoscopy was performed).

Detailed description: Patients will be identified as eligible by the attending Gastroenterologist during the course of a usual consultation. Patients will be referred to the research nurse in the doctor's office for further information regarding the study and informed consent will be obtained by the research nurse.

Upon enrollment, the physician or the research nurse will complete an online requisition form with a unique code which will provide the baseline data. The patient will be provided with the Easy Sampler™ collection kit and instructions on the use of this kit and location on where to send the specimen.

The nurse will then send an email to the research nurse in the originating physician's office with the result of the calprotectin assay. The research nurse will review the result with the physician. After physician review, either the physician or the research nurse will then complete a follow up survey online.

After completion of the assays and surveys, the data will be tabulated electronically from the online website and analyzed by the PI and/or co-investigators.

Eligibility criteria: Inclusion Criteria:

* Subjects must be at least 19 years of age or older, they must be able to read and provide written consent in English.

Subjects will have gastrointestinal symptoms or be known to have Inflammatory Bowel Disease whereby the clinician feels that obtaining Fecal Calprotectin may be useful in the care of the patient. Patients must be able to collect a feces sample and return it for analysis within 3 days

Exclusion Criteria:

* Known Ischemic colitis, infectious enteritis or colitis, known colorectal cancer, history of extensive bowel resection, ostomy, current daily use of NSAIDs (aspirin, ibuprofen, naproxen, etc) or the inability to collect sample and return it within 3 days

Primary outcomes:
measure: Percentage of time that Fecal Calprotectin result caused the physician to change the management of a patient.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GI Research Institute (GIRI)
state: British Columbia
Study officials:
affiliation: Department of Medicine, Division of Gastroenterology, UBC
name: Brian Bressler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sutherland AD, Gearry RB, Frizelle FA. Review of fecal biomarkers in inflammatory bowel disease. Dis Colon Rectum. 2008 Aug;51(8):1283-91. doi: 10.1007/s10350-008-9310-8. Epub 2008 Jun 10.
citation: Gisbert JP, Bermejo F, Perez-Calle JL, Taxonera C, Vera I, McNicholl AG, Algaba A, Lopez P, Lopez-Palacios N, Calvo M, Gonzalez-Lama Y, Carneros JA, Velasco M, Mate J. Fecal calprotectin and lactoferrin for the prediction of inflammatory bowel disease relapse. Inflamm Bowel Dis. 2009 Aug;15(8):1190-8. doi: 10.1002/ibd.20933.
citation: Schoepfer AM, Beglinger C, Straumann A, Trummler M, Vavricka SR, Bruegger LE, Seibold F. Fecal calprotectin correlates more closely with the Simple Endoscopic Score for Crohn's disease (SES-CD) than CRP, blood leukocytes, and the CDAI. Am J Gastroenterol. 2010 Jan;105(1):162-9. doi: 10.1038/ajg.2009.545. Epub 2009 Sep 15.
citation: Keohane J, O'Mahony C, O'Mahony L, O'Mahony S, Quigley EM, Shanahan F. Irritable bowel syndrome-type symptoms in patients with inflammatory bowel disease: a real association or reflection of occult inflammation? Am J Gastroenterol. 2010 Aug;105(8):1788, 1789-94; quiz 1795. doi: 10.1038/ajg.2010.156. Epub 2010 Apr 13.