Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Completed

Conditions: Ulcerative Colitis; Crohn's Disease

Treatments: Dietary Supplement: Eicosapentaenoic acid; Dietary Supplement: Medium chain fatty acid (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT02179372

EPA/CALPRO

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Eicosapentaenoic acid

Experimental group

Description:

Subject with Cronn's Disease and/or Ulcerative colitis in clinical remission will receive 2 g/day of eicosapentaenoic acid for 6 months

Treatment:

Dietary Supplement: Eicosapentaenoic acid

Medium chain fatty acid (placebo)

Placebo Comparator group

Description:

Subjects with Crohn's Disease and/or Ulcerative colitis will be receive 2 g/day of medium chain fatty acid for 6 months

Treatment:

Dietary Supplement: Medium chain fatty acid (placebo)