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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 2016 |
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Main ID: |
NCT02179372 |
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Date of registration:
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29/06/2014 |
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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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Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases
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Scientific title:
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Modulation of Fecal Calprotectin by Eicosapentaenoic Free Fatty Acid in Inflammatory Bowel Diseases |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02179372 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age ranged between18 and 80 years.
- Patients with Ulcerative Colitis (diagnosed on the base of clinic, endoscopic and
histologic criteria) in clinical remission (SCCAI = 0) from at least 3 months and in
stable therapy (without therapeutic modifications in the three previous months) with
5-ASA, immunomodulators and/or biologics.
- Patients affected by Crohn's Disease (diagnosed on the base of clinic, endoscopic and
histologic criteria) ) in clinical remission (CDAI < 150) from at least 3 months and
in stable therapy (without therapeutic modifications in the three previous months)
with 5-ASA, immunomodulators and/or biologics.
- Fecal calprotectin at baseline > 150 µg/g.
Exclusion Criteria:
- Patients affected by Ulcerative Colitis and Crohn's Disease respectively with a SCCAI
= 1 and a CDAI =150.
- Patients on steroid therapy.
- Patients in therapy wih warfarin or other anticoagulants.
- Known or supposed ipersensitivity to eicosapentaenoic acid/omega 3.
- Women in fertile age which refuse to use contracceptives specified in the study (oral
contraception, IUD) and breastfeed women.
- Patients with severe clinical conditions which the investigator consider to
controindicate patient partecipation at the study.
- Therapy modifications and/or assumption of sperimental therapies within three months
before the study inclusion.
- Patients unable to follow protocol procedures and to sign the informate consent.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Ulcerative Colitis
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Intervention(s)
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Dietary Supplement: Eicosapentaenoic acid
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Dietary Supplement: Medium chain fatty acid (placebo)
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Primary Outcome(s)
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changes in fecal calprotectin levels
[Time Frame: baseline, 3 months and at 6 months]
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Secondary Outcome(s)
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number of clinical flares of diseases
[Time Frame: at 6 months]
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Secondary ID(s)
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EPA/CALPRO
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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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