NCT03633669

Effect of Real-world Tight Control Management of Inflammatory Bowel Disease

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fecal calprotectin	Testing every 3 months
OTHER	Routine care	As per treating gastroenterologist

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-08-16
• Last updated: 2019-08-15