Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases

Not Applicable

Completed

• Conditions: Crohn's Disease; Ulcerative Colitis
• Interventions: Dietary Supplement: Eicosapentaenoic acid; Dietary Supplement: Medium chain fatty acid (placebo)

• Registration Number: NCT02179372
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-29
• Study First Submitted QC: 2014-06-29
• Study First Posted: 2014-07-01
• Primary Completion: 2016-10
• Status Verified: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eicosapentaenoic acid	Eicosapentaenoic acid	Subject with Cronn's Disease and/or Ulcerative colitis in clinical remission will receive 2 g/day of eicosapentaenoic acid for 6 months
Medium chain fatty acid (placebo)	Medium chain fatty acid (placebo)	Subjects with Crohn's Disease and/or Ulcerative colitis will be receive 2 g/day of medium chain fatty acid for 6 months

Primary Outcome Measures

Name	Time	Method
changes in fecal calprotectin levels	baseline, 3 months and at 6 months

Secondary Outcome Measures

Name	Time	Method
number of clinical flares of diseases	at 6 months

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi; 🇮🇹 Bologna, Italy