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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02069561
First Posted: February 24, 2014
Last Update Posted: September 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Luigi Ricciardiello, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
  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: None (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 Luigi Ricciardiello, 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 ]
  • 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 ]

Secondary Outcome Measures:
  • Changes of circulating cytokines from baseline [ Time Frame: baseline and 3 months ]
  • Changes of membrane fatty acid composition from baseline [ Time Frame: baseline and 3 months ]
  • Changes of metabolomic profiles from baseline [ Time Frame: baseline and 3 months ]
  • Change of Microbiota composition from baseline [ Time Frame: baseline and 3 months ]

Enrollment: 25
Study Start Date: January 2014
Primary Completion Date: August 2015 (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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069561


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

Responsible Party: Luigi Ricciardiello, Associate 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
First Submitted: February 19, 2014
First Posted: February 24, 2014
Last Update Posted: September 18, 2015
Last Verified: September 2015

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