Crohn's Disease, Ulcerative Colitis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTEicosapentaenoic 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_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.
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in fecal calprotectin levels | baseline, 3 months and at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| number of clinical flares of diseases | at 6 months |
Countries
Italy
Outcome results
None listed