Clinical Trials Directory

Trials / Completed

CompletedNCT02179372

Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTEicosapentaenoic acid30 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.
DIETARY_SUPPLEMENTMedium 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.

Timeline

Start date
2014-06-01
Primary completion
2016-10-01
Completion
2016-11-01
First posted
2014-07-01
Last updated
2016-11-29

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT02179372. Inclusion in this directory is not an endorsement.