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| Name | Class |
|---|---|
| MDC Associates, LLC | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD | Adult subjects diagnosed with IBD via endoscopy and histological findings. |
| |
| IBS | Adult subjects with IBS as per the Rome IV criteria. |
| |
| Other GI Disorders | Adult subjects with gastrointestinal disorders not meeting the Rome IV criteria or IBD diagnosis. |
| |
| Healthy Subjects | Adult subjects without any gastrointestinal complaints. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Calprotectin Level | Device | Measurement of calprotectin in feces |
|
| Measure | Description | Time Frame |
|---|---|---|
| In vitro diagnostic value of Calprotectin | Value of calprotectin measurement in the ELISA | Through study completion, up to 52 weeks. |
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Inclusion Criteria:
Inclusion Criteria (IBD or IBS subjects):
Inclusion Criteria (normal subjects):
Exclusion Criteria:
Exclusion Criteria (IBD or IBS Subjects):
Exclusion Criteria (normal subjects):
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Individuals that presents with symptoms of IBS/IBD and otherwise healthy subjects
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| Name | Affiliation | Role |
|---|---|---|
| Fran White | MDC Associates | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ALPCO | Salem | New Hampshire | 03079 | United States |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Stool
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |