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Inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis, is a condition that causes inflammation in the gastrointestinal tract. The disease goes through periods of remission and flare. Biomarkers such as fecal calprotectin have been proposed as a tool to monitor disease activity. Fecal calprotectin is a test that measures the amount of inflammation in the stool. Monitoring fecal calprotectin levels can assist gastroenterologists in making decisions regarding patients' IBD treatment such as whether to increase the dose of medications. A recent study showed that frequent measurement of fecal calprotectin every 3 months, also called the tight-control strategy, was associated with improved clinical outcomes in IBD patients. The purpose of this study is to assess whether the tight-control monitoring strategy, which includes fecal calprotectin monitoring every 3 months, improves clinical outcomes in IBD when performed in the real world compared to routine clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tight control | Active Comparator | Group that will receive fecal calprotectin testing every 3 months |
|
| Standard care | Placebo Comparator | Routine clinical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal calprotectin | Diagnostic Test | Testing every 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Relapse | This will be a composite outcome of clinical symptom relapse (based on elevation of symptom scores like rise in Harvey Bradshaw Index >=3 points for Crohn's disease and Partial Mayo score >=2 points for ulcerative colitis), hospitalization, prednisone use, or IBD-related surgery | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Clinical symptom relapse | Elevation of symptom scores like rise in Harvey Bradshaw Index >= 3 points for Crohn's disease and Partial Mayo score >=2 points for ulcerative colitis | 12 months |
| Incidence of Hospitalizations |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Routine care |
| Other |
As per treating gastroenterologist |
|
Based on admission to hospital for IBD-related reasons
| 12 months |
| Incidence of change in medical therapies | Increased doses of current biologics, switch to different biologics, addition of immunomodulators, or steroid use would all qualify as changes in medical therapies | 12 months |