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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Eicosapentaenoic Acid
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Eicosapentaenoic Acid

Normal controls

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Changes of RNA profiles (gene expression and micro RNA) from baseline
Changes of DNA methylation profiles
Changes in cell proliferation
Changes of apoptosis

Secondary Outcome Measures

Changes of circulating cytokines from baseline
Changes of membrane fatty acid composition from baseline
Changes of metabolomic profiles from baseline
Change of Microbiota composition from baseline

Full Information

First Posted
February 19, 2014
Last Updated
September 17, 2015
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT02069561
Brief Title
Effects of Eicosapentaenoic Acid on Subjects at High Risk for Colorectal Cancer
Acronym
EPAUC
Official Title
Effects of Eicosapentaenoic Acid on Molecular, Metabonomics and Intestinal Microbiota Changes, in Subjects With Long-standing Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eicosapentaenoic Acid
Arm Type
Experimental
Arm Description
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
Arm Title
Normal controls
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Eicosapentaenoic Acid
Other Intervention Name(s)
ALFA ™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of RNA profiles (gene expression and micro RNA) from baseline
Time Frame
baseline and at 3 months
Title
Changes of DNA methylation profiles
Time Frame
baseline and 3 months
Title
Changes in cell proliferation
Time Frame
baseline and 3 months
Title
Changes of apoptosis
Time Frame
baseline and 3 months
Secondary Outcome Measure Information:
Title
Changes of circulating cytokines from baseline
Time Frame
baseline and 3 months
Title
Changes of membrane fatty acid composition from baseline
Time Frame
baseline and 3 months
Title
Changes of metabolomic profiles from baseline
Time Frame
baseline and 3 months
Title
Change of Microbiota composition from baseline
Time Frame
baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Ricciardiello, MD
Organizational Affiliation
Azienda Ospedaliero Universitaria Policlinico S.Orsola Malpighi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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