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Sponsor decided to discontinue the study due to poor enrollment.
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To evaluate the relationship between noninvasive biomarkers (patient serological markers and metagenomic analysis of stool) and disease status as determined by colonoscopy and by clinical symptoms in patients with Crohn's disease, and to evaluate whether changes in the biomarker levels over time correlate to changes in the state of patients' disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group | Other | This is a prospective, longitudinal descriptive study of subjects with diagnosed Crohn's disease. Blood samples for measurement of protein biomarkers (serology), fresh whole blood for detection of gene polymorphisms, and stool samples for detection and assessment of microbiome and host DNA will be collected, and colonoscopy will be performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy | Procedure | Colonoscopy will be required for all subjects at 6 months - Visit 3. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess disease status biomarkers against colonoscopy | The primary endpoint for assessing clinical validity of candidate biomarker will be correlation to the degree of mucosal healing as determined by colonoscopy scored by the Simple Endoscopic Score for Crohn's Disease (SES-CD). - A scale that via colonoscopy of Crohn's disease patients measures: 1. Presence and size of ulcers 2. Extent of ulcerated surface 3. Extent of affected surface and 4. Presence and type of intestinal narrowings. Scale goes from 0 to 56 with a higher score indicating greater severity of disease. | 6 months |
| Assess disease status biomarkers against colonoscopy | The primary endpoint for assessing clinical validity of candidate biomarker will also be correlated to the degree of mucosal healing as determined by colonoscopy scored by the Crohn's Disease Endoscopic Index of Severity (CDEIS). A scale that via colonoscopy of Crohn's disease patient's measures: 1. Deep Ulcerations 2. Superficial Ulcerations 3. Surface involved by disease and 4.Surface involved by ulcerations. Scale goes from 0 to 44 with a higher score indicating greater severity of disease. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess bacterial markers in stool against colonoscopy scoring system Simple Endoscopic Score for Crohn's Disease (SES-CD) | Identify the correlation of the quantity of specific bacterial markers in the stool as quantified by a stool-based algorithm to the clinical state of the colonoscopy procedure scored by SES-CD tool. Simple Endoscopic Score for Crohn's Disease (SES-CD) - A scale that via colonoscopy of Crohn's disease patients measures: 1.Presence and size of ulcers 2. Extent of ulcerated surface 3. Extent of affected surface and 4. Presence and type of intestinal narrowings. Scale goes from 0 to 56 with a higher score indicating greater severity of disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development and Medical Affairs | Prometheus Laboratories | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Ventura Clinical Trials, LLC. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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All study subjects will undergo a protocol required 6 month colonoscopy
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| 6 months |
| Assess bacterial markers in stool against colonoscopy scoring system Crohn's Disease Endoscopic Index of Severity (CDEIS) | Identify the correlation of the quantity of specific bacterial markers in the stool as quantified by a stool-based algorithm to the clinical state of the colonoscopy procedure scored by CDEIS tool. Crohn's Disease Endoscopic Index of Severity (CDEIS) ) - A scale that via colonoscopy of Crohn's disease patient's measures: 1. Deep Ulcerations 2. Superficial Ulcerations 3. Surface involved by disease and 4.Surface involved by ulcerations. Scale goes from 0 to 44 with a higher score indicating greater severity of disease. | 6 months |
| Assess bacterial markers in stool against disease symptomology scored by Harvey Bradshaw Index (HBI) for clinical evaluation | Determine the correlation of the quantity of specific bacterial markers in the stool as quantified by a stool-based algorithm to the clinical symptoms that measure stool frequency and symptomology by the Harvey Bradshaw Index (HBI) tool. Harvey Bradshaw Index (HBI) - A scale that assesses Crohn's disease patients' signs and symptoms by measuring : 1. General well-being 2. Abdominal pain 3. Number of liquid stools per day 4. Presence of abdominal mass and 5. Complications. Scale goes from 0 to 18 with a higher score indicating greater severity of disease. | 6 months |
| Assess bacterial markers in stool against disease symptomology scored by Crohn's Disease Activity Index (CDAI) for clinical evaluation | Determine the correlation of the quantity of specific bacterial markers in the stool as quantified by a stool-based algorithm to the clinical symptoms that measure stool frequency and symptomology by the Crohn's Disease Activity Index (CDAI) tool. Crohn's Disease Activity Index (CDAI) - A scale that assesses Crohn's disease patients' signs and symptoms by measuring: 1. Number of liquid or soft stools each day for seven days 2. Abdominal pain each day for seven day 3. General well-being, subjectively assessed for day for seven days 4. Presence of complications 5. Taking anti-diarrhea medications 6. Presence of an abdominal mass 7.Hematocrit and 8. Percentage deviation from standard weight. Scale goes from 0 to >600 with a higher score indicating greater severity of disease. | 6 months |
| Ventura |
| California |
| 93003 |
| United States |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | United States |
| Atlanta Gastroenterology Associates, LLC | Atlanta | Georgia | 30309 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| D007410 | Intestinal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |