Effects of Eicosapentaenoic Acid on Subjects at High Risk for Colorectal Cancer
Information source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ulcerative Colitis
Intervention: Eicosapentaenoic Acid (Dietary Supplement)
Phase: N/A
Status: Recruiting
Sponsored by: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi Official(s) and/or principal investigator(s): Luigi Ricciardiello, MD, Principal Investigator, Affiliation: Azienda Ospedaliero Universitaria Policlinico S.Orsola Malpighi
Overall contact: Luigi Ricciardiello, MD, Phone: +393669614317, Email: luigi.ricciardiello@unibo.it
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.
Clinical Details
Official title: Effects of Eicosapentaenoic Acid on Molecular, Metabonomics and Intestinal Microbiota Changes, in Subjects With Long-standing Inflammatory Bowel Disease
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Changes of RNA profiles (gene expression and micro RNA) from baselineChanges of DNA methylation profiles Changes in cell proliferation Changes of apoptosis
Secondary outcome: Changes of circulating cytokines from baselineChanges of membrane fatty acid composition from baseline Changes of metabolomic profiles from baseline Change of Microbiota composition from baseline
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Luigi Ricciardiello, MD, Phone: +393669614317, Email: luigi.ricciardiello@unibo.it
Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi, Bologna, BO 40138, Italy; Recruiting Luigi Ricciardiello, MD, Phone: +393669614317, Email: luigi.ricciardiello@unibo.it Luigi Ricciardiello, MD, Principal Investigator
Additional Information
Starting date: January 2014
Last updated: June 24, 2015
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