ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool

Study Overview
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Brief Summary
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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.

Official Title
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ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool

Conditions
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Inflammatory Bowel Diseases, Irritable Bowel Syndrome

Intervention / Treatment
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* Device: Fecal Calprotectin Level


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Exclusion Criteria (IBD or IBS Subjects): patient under the age of 18 Patient taking NSAIDs Patients not presenting with signs or symptoms of IBS or IBD with the exception of 100 normal patients to be included in the study. Fifty (50) presenting for routine colonoscopy and 50 patients presenting with no disease symptoms and not scheduled for a colonoscopy. Patients not scheduled to have an colonoscopy unless enrolled in the study as normal population Exclusion Criteria (normal subjects): Unable or unwilling to provide a stool specimen. Have taken protein pump inhibitors (PPIs) or H2-receptor antagonists for control of upper GI disease within the previous 2 weeks. Have taken NSAIDs (including aspirin) on within 2 weeks of study enrollment.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IBD<br>Adult subjects diagnosed with IBD via endoscopy and histological findings. | Device: Fecal Calprotectin Level<br>* Measurement of calprotectin in feces<br>|
| IBS<br>Adult subjects with IBS as per the Rome IV criteria. | Device: Fecal Calprotectin Level<br>* Measurement of calprotectin in feces<br>|
| Other GI Disorders<br>Adult subjects with gastrointestinal disorders not meeting the Rome IV criteria or IBD diagnosis. | Device: Fecal Calprotectin Level<br>* Measurement of calprotectin in feces<br>|
| Healthy Subjects<br>Adult subjects without any gastrointestinal complaints. | Device: Fecal Calprotectin Level<br>* Measurement of calprotectin in feces<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In vitro diagnostic value of Calprotectin | Value of calprotectin measurement in the ELISA | Through study completion, up to 52 weeks. |