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

Acute Severe Colitis (ASC) Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02922374
• Other study ID #: ASC-UCEIS-FC
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: September 28, 2016
• Last updated: October 20, 2016
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 117
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Severe Colitis (ASC)
• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• corticosteroids
Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.

Locations

Country	Name	City	State
China	Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stool frequency at day 3	The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria.	3 days	No
Primary	C-reactive protein (CRP) at day 3	The response to intravenous steroid therapy was judged at day 3 according to Oxford criteria.	3 days	No
Secondary	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).	3 days	No
Secondary	Fecal Calprotectin before treatment	FC was measured strictly with the instruction of the commercial test kits.	3 days	No