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The primary objective is to obtain stool samples from subjects diagnosed with , and displaying signs and/or symptoms of IBD and/or IBS will be evaluated in this study. Eligible subjects require a diagnostic colonoscopy with possible biopsy and clinical evaluation.
Stools will be collected and tested, at a later date, in a clinical performance study with an investigational Calprotectin assay. This study will be coordinated by the Sponsor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inflammatory Bowel Disease (IBD) | A stool sample will be collected from adult subjects with Inflammatory Bowel Disease (IBD), confirmed by endoscopy and histologic examination. |
| |
| Irritable Bowel Syndrome (IBS) | A stool sample will be collected from adult subjects with adult subjects with Irritable Bowel Syndrome meeting the Rome III criteria. |
| |
| Other GastroIntestinal (GI) Disorders | A stool sample will be collected from adult subjects with adult subjects with gastrointestinal disorders other than IBD or IBS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool collection | Diagnostic Test | Stool sample collected by a subject who have been diagnosed with IBD, IBS or other GI disorder. The stool sample is tested in a laboratory where fecal calprotectin levels are quantified. |
| Measure | Description | Time Frame |
|---|---|---|
| Calprotectin Stool Collection | In vitro diagnostic (IVD) device performance | Through Study Completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects and belonging to the target population, i.e. patients diagnosed with IBD, specifically CD, UC, or IC, patients diagnosed with IBS, and patients diagnosed with other gastrointestinal diseases, e.g. Celiac Disease, Diverticular Disease, Chronic Diarrhea and Recurrent Abdominal Pain (RAP).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| One (1) Location in Dothan, Alabama | Dothan | Alabama | 36305 | United States | ||
| One (1) Facility in Arkansas |
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Human Stool
| Little Rock |
| Arkansas |
| 72117 |
| United States |
| One (1) Location in California | Mission Hills | California | 91345 | United States |
| One (1) Location in Colorado Springs, Colorado | Colorado Springs | Colorado | 80907 | United States |
| One (1) Location in Lauderdale Lakes, FL | Lauderdale Lakes | Florida | 33319 | United States |
| One (1) Location in Maitland, FL | Maitland | Florida | 32751 | United States |
| One (1) Location in Miami, Florida | Miami | Florida | 33134 | United States |
| One (1) Location in St. Augustine, FL | Saint Augustine | Florida | 32086 | United States |
| One (1) Location in Atlanta, GA | Atlanta | Georgia | 30342 | United States |
| One (1) Location in Minneapolis, MN | Minneapolis | Minnesota | 55455 | United States |
| One (1) Location in New York, New York | New York | New York | 33134 | United States |
| One (1) Location in North Carolina | Asheville | North Carolina | 28801 | United States |
| One (1) Location in Greenville, SC | Greenville | South Carolina | 29615 | United States |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D043183 | Irritable Bowel Syndrome |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D002446 | Celiac Disease |
| D004238 | Diverticulitis |
| D015746 | Abdominal Pain |
| D004108 | Dilatation, Pathologic |
| D015431 | Weight Loss |
| D000073923 | Food Intolerance |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D003092 | Colitis |
| D008286 | Malabsorption Syndromes |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000076385 | Diverticular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D020763 | Pathological Conditions, Anatomical |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
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