Status:
TERMINATED
Exclusive Enteral Nutrition and Corticosteroids Therapy in Crohn's Disease (EENCD)
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Société des Produits Nestlé (SPN)
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study evaluates the effect of Exclusive Enteral Nutrition (EEN) in addition to different regimes of corticosteroid (CS) therapy (Prednisone) compared to CS alone in adults participants with activ...
Detailed Description
Crohn's disease (CD) is an inflammatory bowel disease (IBD) characterized by diarrhea, abdominal pain and bleeding. There are several treatment options but the most-widely used for acute therapy are c...
Eligibility Criteria
Inclusion
- Confirmed CD for at least 6 months
- Clinically active disease (CDAI \>220 or Harvey-Bradshaw Index (HBI) \>6) or active by endoscopy.
- Biochemical evidence of disease activity (CRP \>5 and/or fecal calprotectin \>250)
Exclusion
- Currently using EEN
- Condition that would preclude the use of EEN, such as Intestinal obstruction, perforation, toxic megacolon, massive gastrointestinal bleeding, abdominal abscess, or stricturing disease
- Previous intestinal resection with a remnant bowel of less than 180 cm
- Treatment with Prednisone in the last 30 days
- New start or change in dose of azathioprine, 6-mercaptopurine, cyclosporine, other immunosuppressant or biologics in the last 90 days. Doses of these medications must also remain unchanged for the duration of the study
- New start or change in dose of 5-aminosalicylic acid (ASA) in the last 30 days. 5ASA dose must remain unchanged for the duration of the study
- Use of Antibiotics or Probiotics in the last 30 days
- Pregnant or Lactating
- Any serious illness which could interfere with study procedures or results
Key Trial Info
Start Date :
October 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03833596
Start Date
October 25 2018
End Date
November 1 2019
Last Update
September 2 2020
Active Locations (1)
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1
McMaster University
Hamilton, on, Ontario, Canada, L8S 4K1