NCT01705522

Multimodal Approach in IBD Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Clinical Hospital Colentina · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The investigators intend to assess the role of several biomarkers in the prediction of relapse in IBD. Clinical, laboratory and endoscopic data will be gathered and a predictive score will be derived in order to assess the relapse risk at 1 year.

Detailed description

Patients with a confirmed diagnosis of IBD will be prospectively assessed on a yearly basis in order to assess relapse risk factors. Disease activity will be assessed using the Mayo score for UC patients and CDAI for Crohn's disease and endoscopic activity will be assessed using the Mayo endoscopic subscore for UC patients and the Simple Endoscopic Score for Crohn's Disease for CD patients. Serum and fecal biomarkers will be obtainted at each study visit (C-reactive protein, fecal calprotectin). Data about current and past medication for IBD will also be gathered.

Conditions

• Ulcerative Colitis
• Crohn's Disease
• Nonalcoholic Fatty Liver Disease (NAFLD)
• Vitamin D Deficiency

Timeline

• Start date: 2012-10-01
• Primary completion: 2019-09-01
• Completion: 2019-10-01
• First posted: 2012-10-12
• Last updated: 2019-01-31

Locations

1 site across 1 country: Romania