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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Sponsor:
Information provided by (Responsible Party):
Luigi Ricciardiello, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT02069561
First received: February 19, 2014
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Ulcerative Colitis
Dietary Supplement: Eicosapentaenoic Acid

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Eicosapentaenoic Acid on Molecular, Metabonomics and Intestinal Microbiota Changes, in Subjects With Long-standing Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:

Primary Outcome Measures:
  • Changes of RNA profiles (gene expression and micro RNA) from baseline [ Time Frame: baseline and at 3 months ] [ Designated as safety issue: No ]
  • Changes of DNA methylation profiles [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • Changes in cell proliferation [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • Changes of apoptosis [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes of circulating cytokines from baseline [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • Changes of membrane fatty acid composition from baseline [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • Changes of metabolomic profiles from baseline [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • Change of Microbiota composition from baseline [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: January 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02069561

Contacts
Contact: Luigi Ricciardiello, MD +393669614317 luigi.ricciardiello@unibo.it

Locations
Italy
Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi Recruiting
Bologna, BO, Italy, 40138
Contact: Luigi Ricciardiello, MD    +393669614317    luigi.ricciardiello@unibo.it   
Principal Investigator: Luigi Ricciardiello, MD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
Principal Investigator: Luigi Ricciardiello, MD Azienda Ospedaliero Universitaria Policlinico S.Orsola Malpighi
  More Information

No publications provided

Responsible Party: Luigi Ricciardiello, Assistant Professor of Gastroenterology, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT02069561     History of Changes
Other Study ID Numbers: EPAUC/2013
Study First Received: February 19, 2014
Last Updated: June 26, 2014
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014