FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of Inflammatory Bowel Disease (IBD)

NCT01676324 | Completed DMC

• 1 other identifier: H12-01499
• Study Type: observational
• Target: 289
• Locations: 1 country
• Sites: 1

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. 1.To determine if the Fecal Calprotectin result influenced the number of endoscopies performed
2. 2.To correlate how well the Fecal Calprotectin correlates with Endoscopic findings when endoscopy was performed.
3. 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).

Conditions

Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

Keywords

Fecal Calprotectin

Outcome Measures

Primary Outcomes (1)

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

  The utility of the test will be assessed by comparing the proportion of time the test altered management for each of the two groups (IBD present vs. IBD absent). The groups will be compared using paired t-tests and McNemar's test as appropriate. Multivariate analysis will be used to assess the impact of the baseline variables on the test utility.

  one year

Study Arms (1)

Inflammatory Bowel Disease

Those with Inflammatory Bowel Disease (known) and those with no Inflammatory Bowel Disease (not previously diagnosed)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

GI Research Institute (GIRI)

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Related Publications (4)

• 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.

  PMID: 18543035 BACKGROUND

• 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.

  PMID: 19291780 BACKGROUND

• 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.

  PMID: 19755969 BACKGROUND

• 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.

  PMID: 20389294 RESULT

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Brian Bressler, MD

  Department of Medicine, Division of Gastroenterology, UBC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: August 30, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 9, 2014

Record last verified: 2014-06

Locations

CA (1)