Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis
1 other identifier
interventional
117
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2013
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 28, 2016
CompletedFirst Posted
Study publicly available on registry
October 4, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedOctober 24, 2016
October 1, 2016
3.4 years
September 28, 2016
October 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
ulcerative colitis endoscopic index of severity (UCEIS) before treatment
3 days
Fecal Calprotectin before treatment
3 days
Study Arms (1)
CS
EXPERIMENTALIntravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.
Interventions
Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, 210000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
September 28, 2016
First Posted
October 4, 2016
Study Start
January 1, 2013
Primary Completion
June 1, 2016
Study Completion
December 1, 2016
Last Updated
October 24, 2016
Record last verified: 2016-10