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OpenTrials
Completed

NCT Number: NCT02069561

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

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.

Completed

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi

Bologna, BO, 40138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ALFA ™

Primary outcomes

  1. Changes of RNA profiles (gene expression and micro RNA) from baseline

    Time frame: baseline and at 3 months

  2. Changes of DNA methylation profiles

    Time frame: baseline and 3 months

  3. Changes in cell proliferation

    Time frame: baseline and 3 months

  4. Changes of apoptosis

    Time frame: baseline and 3 months

Secondary outcomes

  1. Changes of circulating cytokines from baseline

    Time frame: baseline and 3 months

  2. Changes of membrane fatty acid composition from baseline

    Time frame: baseline and 3 months

  3. Changes of metabolomic profiles from baseline

    Time frame: baseline and 3 months

  4. Change of Microbiota composition from baseline

    Time frame: baseline and 3 months

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: EPAUC

Important dates

Study start
2014
Primary completion
2015
First posted
Feb 24, 2014
Registry last updated
Sep 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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