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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 September 2015
• Main ID: NCT02069561
• Date of registration: 19/02/2014
• Prospective Registration: No
• Primary sponsor: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Public title: Effects of Eicosapentaenoic Acid on Subjects at High Risk for Colorectal Cancer EPAUC
• Scientific title: Effects of Eicosapentaenoic Acid on Molecular, Metabonomics and Intestinal Microbiota Changes, in Subjects With Long-standing Inflammatory Bowel Disease
• Date of first enrolment: January 2014
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02069561
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

Italy

Contacts

• Name: Luigi Ricciardiello, MD
• Affiliation: Azienda Ospedaliero Universitaria Policlinico S.Orsola Malpighi

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Dietary Supplement: Eicosapentaenoic Acid

Primary Outcome(s)

Changes of DNA methylation profiles [Time Frame: baseline and 3 months]

Changes in cell proliferation [Time Frame: baseline and 3 months]

Changes of apoptosis [Time Frame: baseline and 3 months]

Changes of RNA profiles (gene expression and micro RNA) from baseline [Time Frame: baseline and at 3 months]

Secondary Outcome(s)

Changes of circulating cytokines from baseline [Time Frame: baseline and 3 months]

Changes of metabolomic profiles from baseline [Time Frame: baseline and 3 months]

Changes of membrane fatty acid composition from baseline [Time Frame: baseline and 3 months]

Change of Microbiota composition from baseline [Time Frame: baseline and 3 months]

Secondary ID(s)

EPAUC/2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors