Back to resultsUlcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis
Primary Purpose
Acute Severe Colitis (ASC)
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
corticosteroids
Sponsored by
About this trial
This is an interventional treatment trial for Acute Severe Colitis (ASC) focused on measuring acute severe colitis, corticosteroids, UCEIS, fecal calprotectin
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.
Sites / Locations
- Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CS
Arm Description
Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.
Outcomes
Primary Outcome Measures
stool frequency at day 3
The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria.
C-reactive protein (CRP) at day 3
The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria.
Secondary Outcome Measures
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).
Fecal Calprotectin before treatment
FC was measured strictly with the instruction of the commercial test kits.
Full Information
NCT ID
NCT02922374
First Posted
September 28, 2016
Last Updated
October 20, 2016
Sponsor
Jinling Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT02922374
Brief Title
Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Severe Colitis (ASC)
Keywords
acute severe colitis, corticosteroids, UCEIS, fecal calprotectin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CS
Arm Type
Experimental
Arm Description
Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.
Intervention Type
Drug
Intervention Name(s)
corticosteroids
Intervention Description
Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.
Primary Outcome Measure Information:
Title
stool frequency at day 3
Description
The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria.
Time Frame
3 days
Title
C-reactive protein (CRP) at day 3
Description
The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
ulcerative colitis endoscopic index of severity (UCEIS) before treatment
Description
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).
Time Frame
3 days
Title
Fecal Calprotectin before treatment
Description
FC was measured strictly with the instruction of the commercial test kits.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis
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