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

Study Overview
=================
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.

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

Conditions
-----------------
Acute Severe Colitis (ASC)

Intervention / Treatment
-----------------
* Drug: corticosteroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a confirmed diagnosis of ASC according to Truelove and Witt's criteria; Patients were generally able to tolerate the flexible colonoscopy before start of CS treatment; Exclusion Criteria: Patients with incomplete colonoscopy, inadequate fecal sample; Patients with indeterminate diagnosis of ASC (colorectal cancer, Crohn's disease) according to colonoscopy; Patients with infectious colitis, Clostridium difficile and CMV infection, primary immunodeficiency, recent history of immunosuppressant within 3 months. Patients with bowel resection, intestinal anastomotic, and ileum enterostomy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CS<br>Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days. | Drug: corticosteroids<br>* Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stool frequency at day 3 | The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria. | 3 days | 
| C-reactive protein (CRP) at day 3 | The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ulcerative colitis endoscopic index of severity (UCEIS) before treatment | 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). | 3 days | 
| Fecal Calprotectin before treatment | FC was measured strictly with the instruction of the commercial test kits. | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute severe colitis, corticosteroids, UCEIS, fecal calprotectin