- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02922374
Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis
October 20, 2016 updated by: Jianfeng Gong, Jinling Hospital, China
Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational Study
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
117
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
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Nanjing, Jiangsu, China, 210000
- Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CS
Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.
|
Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
stool frequency at day 3
Time Frame: 3 days
|
The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria.
|
3 days
|
C-reactive protein (CRP) at day 3
Time Frame: 3 days
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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
Time Frame: 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).
|
3 days
|
Fecal Calprotectin before treatment
Time Frame: 3 days
|
FC was measured strictly with the instruction of the commercial test kits.
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
June 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
September 28, 2016
First Submitted That Met QC Criteria
September 30, 2016
First Posted (Estimate)
October 4, 2016
Study Record Updates
Last Update Posted (Estimate)
October 24, 2016
Last Update Submitted That Met QC Criteria
October 20, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASC-UCEIS-FC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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