Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases

Study Overview
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Brief Summary
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The aim of this study is to test Eicosapentaenoic free fatty acid's effects on calprotectin levels in IBD patients in clinical remission. During the study fecal calprotectin levels will be measured every 3 months and clinical flares will be registered.

Official Title
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Modulation of Fecal Calprotectin by Eicosapentaenoic Free Fatty Acid in Inflammatory Bowel Diseases

Conditions
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Ulcerative Colitis, Crohn's Disease

Intervention / Treatment
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* Dietary Supplement: Eicosapentaenoic acid
* Dietary Supplement: Medium chain fatty acid (placebo)


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eicosapentaenoic acid<br>Subject with Cronn's Disease and/or Ulcerative colitis in clinical remission will receive 2 g/day of eicosapentaenoic acid for 6 months | Dietary Supplement: Eicosapentaenoic acid<br>* 30 subject with Crohn's Disease and/or Ulcerative Colitis in clinical remission but with fecal calprotectin value >150 μg/g will recive 2 g/day of Eicosapentaenoic acid for 6 months treatment. At 3 months and 6 months, fecal calprotectin and clinical activity (CDAI for Crohn's Disease and SCCAI for Ulcerative Colitis) will be measured. The effect of Eicosapentaenoic acid on fecal calprotectin level will be monitored. Clinical relapses will be considered during the study.<br>* Other names: ALFA TM (S.L.A. Pharma A.G. Switzerland);|
| Placebo Comparator: Medium chain fatty acid (placebo)<br>Subjects with Crohn's Disease and/or Ulcerative colitis will be receive 2 g/day of medium chain fatty acid for 6 months | Dietary Supplement: Medium chain fatty acid (placebo)<br>* 30 subject with Crohn's Disease and/or Ulcerative Colitis in clinical remission but with fecal calprotectin value >150 μg/g will recive 2 g/day of medium chain fatty acids for 6 months treatment. At 3 months and 6 months, fecal calprotectin and clinical activity (CDAI for Crohn's Disease and SCCAI for Ulcerative Colitis) will be measured.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in fecal calprotectin levels |  | baseline, 3 months and at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of clinical flares of diseases |  | at 6 months |