Ulcerative Colitis
Conditions
Brief summary
The aim of this study is to test Eicosapentaenoic acid's effects on markers relevant to colorectal carcinogenesis, RNA and DNA profiles, and the possibility that Eicosapentaenoic Acid treatment might be associated with changes of the gut microbiota and metabolomic profiles in patients with long-standing ulcerative colitis.
Interventions
DIETARY_SUPPLEMENTEicosapentaenoic Acid
Twenty patients with long-standing ulcerative colitis undergoing the usual colonoscopic surveillance + biopsy sampling will be recruited. At entry six extra biopsy samples will be collected from the colon. We will also collect blood (for serum, plasma and red cells isolation), urine and stools. Subjects will then receive 2 g/day of Eicosapentaenoic Acid (ALFA ™, SLA Pharma AG, Switzerland) as a supplement for 90 days. At the end of the study each subject will undergo sigmoidoscopy for the collection of 6 biopsies. Blood, urine and stools will be obtained prior to the procedure.
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Arm: experimental Inclusion Criteria: * Patients with ulcerative colitis (diagnosed based on clinical criteria, endoscopic and histological) lasting over 8 years, with no clinical activity (SCCAI = 0), and in stable treatment (without any change in treatment in the previous 3 months) with mesalamine, immunomodulators and / or biologics. * Baseline fecal calprotectin\> 150 micrograms / g. * Signed informed consent.
Exclusion criteria
* Patients receiving systemic steroids in the two months prior to study entry. * Patients taking concomitant warfarin or other blood thinners. * Known or suspected hypersensitivity to eicosapentaenoic acid/omega 3. * Women who are pregnant or of childbearing age who do not accept the use of contraceptive methods specified in the study (oral contraception, IUDs) and breastfeeding women. * Patients with severe medical conditions that, in the opinion of the investigator, contraindicate the patient's participation in the study. * Changes of treatments and / or use of experimental drugs within 3 months before inclusion in the study. * Use of Probiotics Arm: no intervention Inclusion criteria * Subjects undergoing screening colonoscopy within the regional colorectal cancer screening programme * Signed informed consent * Polypectomy with biopsy forceps.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of apoptosis | baseline and 3 months |
| Changes of RNA profiles (gene expression and micro RNA) from baseline | baseline and at 3 months |
| Changes of DNA methylation profiles | baseline and 3 months |
| Changes in cell proliferation | baseline and 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Changes of circulating cytokines from baseline | baseline and 3 months |
| Changes of membrane fatty acid composition from baseline | baseline and 3 months |
| Changes of metabolomic profiles from baseline | baseline and 3 months |
| Change of Microbiota composition from baseline | baseline and 3 months |
Countries
Italy
Outcome results
None listed