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

NCT02069561 | Completed

• 1 other identifier: EPAUC/2013
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (2)

Eicosapentaenoic Acid

EXPERIMENTAL

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

Normal controls

NO INTERVENTION

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.

Interventions

Eicosapentaenoic Acid DIETARY_SUPPLEMENT

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.

Also known as: ALFA ™

Eicosapentaenoic Acid

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Use of Probiotics
• Arm: no intervention
• Subjects undergoing screening colonoscopy within the regional colorectal cancer screening programme
• Signed informed consent
• Polypectomy with biopsy forceps.
• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi

Bologna, BO, 40138, Italy

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Eicosapentaenoic Acid

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Luigi Ricciardiello, MD

  Azienda Ospedaliero Universitaria Policlinico S.Orsola Malpighi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gastroenterology

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 24, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2015
• Last Updated: September 18, 2015

Record last verified: 2015-09

Locations

IT (1)