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
| Type | Name | Description |
|---|---|---|
| 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. |
| DIETARY_SUPPLEMENT | 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. |
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.