Acute Severe Colitis (ASC)
Conditions
Keywords
acute severe colitis, corticosteroids, UCEIS, fecal calprotectin
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.
Interventions
DRUGcorticosteroids
Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.
Sponsors
Jinling Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| stool frequency at day 3 | 3 days | The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria. |
| C-reactive protein (CRP) at day 3 | 3 days | The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed