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

Phase 1

• Conditions: Acute Severe Colitis (ASC)
• Interventions: Drug: corticosteroids

• Registration Number: NCT02922374
• Lead Sponsor: Jinling Hospital, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2016-06
• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-09-30
• Status Verified: 2016-10
• Study First Posted: 2016-10-04
• Last Update Submitted: 2016-10-20
• Last Update Posted: 2016-10-24
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

1. Patients with a confirmed diagnosis of ASC according to Truelove and Witt's criteria;
2. Patients were generally able to tolerate the flexible colonoscopy before start of CS treatment;

Exclusion Criteria

1. Patients with incomplete colonoscopy, inadequate fecal sample;
2. Patients with indeterminate diagnosis of ASC (colorectal cancer, Crohn's disease) according to colonoscopy;
3. Patients with infectious colitis, Clostridium difficile and CMV infection, primary immunodeficiency, recent history of immunosuppressant within 3 months.
4. Patients with bowel resection, intestinal anastomotic, and ileum enterostomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CS	corticosteroids	Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.

Primary Outcome Measures

Name	Time	Method
C-reactive protein (CRP) at day 3	3 days	The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria.
stool frequency at day 3	3 days	The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria.

Secondary Outcome Measures

Name	Time	Method
ulcerative colitis endoscopic index of severity (UCEIS) before treatment	3 days	The UCEIS consists of the following three descriptors and was calculated as a simple sum: vascular pattern (scored 0-2), bleeding (scored 0-3), erosions and ulcers (scored 0-3).
Fecal Calprotectin before treatment	3 days	FC was measured strictly with the instruction of the commercial test kits.

Trial Locations

Locations (1)

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China