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

Effects of Eicosapentaenoic Acid on Molecular, Metabonomics and Intestinal Microbiota Changes, in Subjects With Long-standing Inflammatory Bowel Disease

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Dietary supplement: Eicosapentaenoic Acid

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eicosapentaenoic Acid; 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	Dietary supplement: Eicosapentaenoic 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.; Other Names: ALFA ™
No Intervention: Normal controls; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Changes of apoptosis	baseline and 3 months

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Luigi Ricciardiello, MD, Azienda Ospedaliero Universitaria Policlinico S.Orsola Malpighi

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: February 19, 2014
• First Submitted That Met QC Criteria: February 20, 2014
• First Posted (Estimate): February 24, 2014

Study Record Updates

• Last Update Posted (Estimate): September 18, 2015
• Last Update Submitted That Met QC Criteria: September 17, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: EPAUC/2013