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

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ClinicalTrials.gov Identifier: NCT02922374
Recruitment Status : Unknown
Verified October 2016 by Jianfeng Gong, Jinling Hospital, China.
Recruitment status was:  Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
Jianfeng Gong, Jinling Hospital, China

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.

Condition or disease Intervention/treatment Phase
Acute Severe Colitis (ASC) Drug: corticosteroids Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2013
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CS
Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.
Drug: corticosteroids
Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.




Primary Outcome Measures :
  1. stool frequency at day 3 [ Time Frame: 3 days ]
    The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria.

  2. C-reactive protein (CRP) at day 3 [ Time Frame: 3 days ]
    The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria.


Secondary Outcome Measures :
  1. 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).

  2. Fecal Calprotectin before treatment [ Time Frame: 3 days ]
    FC was measured strictly with the instruction of the commercial test kits.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922374


Locations
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China, Jiangsu
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Jinling Hospital, China

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Responsible Party: Jianfeng Gong, Associate professor, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02922374    
Other Study ID Numbers: ASC-UCEIS-FC
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Keywords provided by Jianfeng Gong, Jinling Hospital, China:
acute severe colitis
corticosteroids
UCEIS
fecal calprotectin
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Hydrocortisone
Anti-Inflammatory Agents