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

NCT ID: NCT02922374

Last Updated: 2016-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Acute Severe Colitis (ASC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CS

Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.

Group Type: EXPERIMENTAL

corticosteroids

Intervention Type: DRUG

Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.

Interventions

corticosteroids

Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Jianfeng Gong

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

ASC-UCEIS-FC

Identifier Type: -

Identifier Source: org_study_id