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

Jinling Hospital, China

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Acute Severe Colitis (ASC)

Treatments: Drug: corticosteroids

Study type: Interventional

Funder types: Other

Identifiers

NCT02922374

ASC-UCEIS-FC

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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117 participants in 1 patient group

CS

Experimental group

Description:

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

Treatment:

Drug: corticosteroids