Effects of Eicosapentaenoic Acid on Subjects at High Risk for Colorectal Cancer (EPAUC)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Dietary Supplement: Eicosapentaenoic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02069561

EPAUC/2013

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Exclusion criteria

• HBV-positive, HCV-positive, HIV-positive or otherwise affected by infectious diseases
• Subjects undergoing chemo and radiation therapy within six months prior to surgery
• Patients receiving systemic steroid in the two months prior to study entry
• Patients undergoing antibiotic therapy within three months prior to the study
• Patients treated with probiotics

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Eicosapentaenoic Acid

Experimental group

Description:

Subjects with long-standing ulcerative colitis and meeting the inclusion criteria will receive 2 g/day of Eicosapentaenoic Acid as a supplement for 90 days

Treatment:

Dietary Supplement: Eicosapentaenoic Acid

Normal controls

No Intervention group

Description:

Five patients undergoing screening colonoscopy and polypectomy using biopsy forceps. Six biopsies of healthy mucosa will be collected at the time of colonoscopy. Faeces, urine and blood samples will be collected prior to performing colonoscopy. The samples will serve as healthy reference for the basic studies.