Inflammatory Bowel Diseases, Irritable Bowel Syndrome
Conditions
Brief summary
The ALPCO Calprotectin ELISA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. This study will estimate the predictive values of a negative (NPV) and positive (PPV) test by utilizing the assay outcomes of the ALPCO Calprotectin ELISA.
Interventions
Measurement of calprotectin in feces
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion Criteria (IBD or IBS subjects): * \>18 years of age * Patient must present with signs and symptoms of IBS or IBD * Patient must be scheduled for a colonoscopy * All results of the colonoscopy including histology must be provided to study site and sponsor. * Medical Chart review may be required to confirm diagnosis of IBS or IBD * Patient must not have taken NSAIDs for at least 2 weeks prior to participating in the study. Patients may be advised of the study and if report taking NSAIDS may be enrolled in the study after the patient has stopped use of NSAIDS for a minimum of 2 weeks. * For normal patient population - study participants must present with no signs or symptoms of IBS or IBD, must not have taken NSAIDs for at least a period of 2 weeks and must be willing to provide a stool sample. * Sample must be collected at least 2-3 days prior to colonoscopy Inclusion Criteria (normal subjects): * Male or female, ≥18 years of age. * No abdominal complaints and no history of IBS, IBD, or other chronic intestinal disorder, confirmed by medical history and physical examination at enrollment. * May have undergone colonoscopy with negative findings within the past 1 month or may have no recent colonoscopy, but scheduled for routine screening colonoscopy. * Able to understand the study and the task required, and sign the ICF.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In vitro diagnostic value of Calprotectin | Through study completion, up to 52 weeks. | Value of calprotectin measurement in the ELISA |
Countries
United States