NCT02922374

Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis

Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational Study

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For acute severe colitis (ASC) patients, corticosteroids (CS) was recommended as the first-line treatment in the guideline, but patients have a great risk of requiring colectomy or turning to second-line treatment. This study aim to verify the effectiveness of ulcerative colitis endoscopic index of severity(UCEIS) in predicting the reaction to corticosteroids, and explores the possibility that noninvasive marker fecal calprotectin (FC) could act as an alternative to UCEIS.

Conditions

• Acute Severe Colitis (ASC)

Interventions

Type	Name	Description
DRUG	corticosteroids	Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2016-10-04
• Last updated: 2016-10-24

Locations

1 site across 1 country: China