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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03833596 |
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Date of registration:
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21/12/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Exclusive Enteral Nutrition and Corticosteroids Therapy in Crohn's Disease (EENCD)
EENCD |
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Scientific title:
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Synergistic Effect of Exclusive Enteral Nutrition Formula in Addition to Corticosteroids Therapy to Induce Clinical Remission in Patients With Crohn's Disease: a Pilot Study Involving a Multidimensional Assessment of Potential Mechanisms |
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Date of first enrolment:
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October 25, 2018 |
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Target sample size:
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3 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03833596 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Contacts
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Name:
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Maria I Pinto-Sanchez, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McMaster University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: Prednisone
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Dietary Supplement: Exclusive Enteral Nutrition
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Primary Outcome(s)
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Efficacy of 6 weeks of EEN and CS in inducing remission (Crohn's Disease Activity Index - CDAI<150) in adult patients with active CD (CDAI>220 and either CRP>5 or fecal calprotectin >250mg/l)
[Time Frame: 2 years]
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Secondary Outcome(s)
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Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing indirect markers of mucosal integrity
[Time Frame: 2 years]
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Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing anxiety and/or depression scores
[Time Frame: 2 years]
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Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing clinical disease improvement
[Time Frame: 2 years]
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Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing changes in microbiota composition
[Time Frame: 2 years]
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Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in increasing body weight and improving nutritional status
[Time Frame: 2 years]
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Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing biochemical remission
[Time Frame: 2 years]
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Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in improving quality of life
[Time Frame: 2 years]
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Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing number of adverse events
[Time Frame: 2 years]
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Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in normalizing colonic transit
[Time Frame: 2 years]
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Secondary ID(s)
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EEN in Crohn
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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