BÜHLMANN fCAL™ ELISA - Aid in Differentiation of IBD From IBS

Inclusion criteria

• Adults or pediatric patients evaluated by a gastroenterological service for investigation of possible inflammatory intestinal disease or IBS. Patients are referred for sub-specialty evaluation of symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia.

• IBD: Eligible subjects will be analyzed as patients with IBD after a confirmed diagnosis of Inflammatory Bowel Disease (CD, UC, or Indeterminate Colitis), based on endoscopy and confirmed by histology of biopsies taken during endoscopy.
• IBS: Eligible candidate subjects can also include patients who are self-referred with the relevant constellation of complaints. Eligible subjects will be enrolled after having a diagnosis of IBS based on the Rome III criteria confirmed by negative endoscopy including the colon and terminal ileum.
• other GI Disorders: Eligible subjects will be enrolled after having a diagnosis of a gastrointestinal disorder other than IBD or IBS, confirmed by endoscopy results and other appropriate diagnostic studies.
• Healthy Controls: Adults (≥22) with no abdominal complaints and no history of IBS, IBD or other chronic intestinal disorder, confirmed by medical history and physical examination at enrolment.
• Individuals of either gender, ≥22 years of age (adult samples) or 2 to -21 years of age (pediatric samples).
• IBD patients whose diagnostic endoscopy occurred within the previous month.
• Individuals able to understand the study and the tasks required, and who sign the Informed Consent Form (adult subjects; ICF) or whose parent/guardian provides consent (ICF) and, if age 7-to-18 years of age, who provide assent (pediatric subjects).

Exclusion criteria

• Individuals unable or unwilling to provide a stool specimen.
• Individuals with known intestinal cancer, intestinal infection, upper gastrointestinal disease
• Individuals receiving chemotherapy or systemic immunosuppressive drugs.
• Individuals who have taken, within the previous 2 weeks, protein pump inhibitors or H2-receptor antagonists.
• Individuals with previously diagnosed Inflammatory Bowel Disease managed with immunomodulators, 5-ASA (5-aminosalicylic acid) or biologic therapies or who have undergone a surgical resection or diversion procedure.
• Individuals who have taken NSAIDs (nonsteroidal anti-inflammatory drugs), including aspirin, on 7 or more days during the 2 weeks before providing the sample.