Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179372
• Other study ID #: EPA/CALPRO
• Status: Completed
• Phase: N/A
• First received: June 29, 2014
• Last updated: November 28, 2016
• Start date: June 2014
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Dietary Supplement:
• Eicosapentaenoic acid
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.
• Medium chain fatty acid (placebo)
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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in fecal calprotectin levels		baseline, 3 months and at 6 months	No
Secondary	number of clinical flares of diseases		at 6 months	No