Ulcerative ColitisEPAUCNCT02069561
Effects of Eicosapentaenoic Acid on Subjects at High Risk for Colorectal Cancer
A study testing Eicosapentaenoic Acid in people with Ulcerative Colitis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Eicosapentaenoic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Subjects undergoing screening colonoscopy within the regional colorectal cancer screening programme
- Signed informed consent
- Polypectomy with biopsy forceps.
Who cannot join
- 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.
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- Use of Probiotics
- Arm: no intervention
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi
Bologna, BO, 40138
About this study
Official title: Effects of Eicosapentaenoic Acid on Molecular, Metabonomics and Intestinal Microbiota Changes, in Subjects With Long-standing Inflammatory Bowel Disease
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Eicosapentaenoic Acid
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eicosapentaenoic AcidDietary supplement
Also called ALFA ™
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.
| Study group | Role | What they receive |
|---|---|---|
| Eicosapentaenoic Acid | Experimental | 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 Receives: Dietary Supplement: Eicosapentaenoic Acid |
| Normal controls | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of RNA profiles (gene expression and micro RNA) from baseline
Measured: baseline and at 3 months
Changes of DNA methylation profiles
Measured: baseline and 3 months
Changes in cell proliferation
Measured: baseline and 3 months
Changes of apoptosis
Measured: baseline and 3 months
Secondary outcomes (4)
Changes of circulating cytokines from baseline
Measured: baseline and 3 months
Changes of membrane fatty acid composition from baseline
Measured: baseline and 3 months
Changes of metabolomic profiles from baseline
Measured: baseline and 3 months
Change of Microbiota composition from baseline
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Ricciardiello, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Luigi Ricciardiello, MD, Principal investigator, Azienda Ospedaliero Universitaria Policlinico S.Orsola Malpighi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069561
- Sponsor's protocol ID
- EPAUC/2013
- Acronym
- EPAUC
- Status last verified
- Sep 2015
- First submitted
- 19 Feb 2014
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Eicosapentaenoic Acid on Molecular, Metabonomics and Intestinal Microbiota Changes, in Subjects With Long-standing Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02069561
- Acronym / sponsor ID
- EPAUC / EPAUC/2013
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2015 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eicosapentaenoic Acid | Experimental | Dietary Supplement: Eicosapentaenoic AcidSubjects with long-standing ulcerative colitis and meeting the inclusion criteria will receive 2 g/day of Eicosapentaenoic Acid as a supplement for 90 days |
| Normal controls | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Subjects undergoing screening colonoscopy within the regional colorectal cancer screening programme
- Signed informed consent
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eicosapentaenoic AcidAlso: ALFA ™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. | Dietary supplement | Eicosapentaenoic Acid |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Ricciardiello, MD principal investigator
Azienda Ospedaliero Universitaria Policlinico S.Orsola Malpighi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eicosapentaenoic Acid in people with Ulcerative Colitis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of RNA profiles (gene expression and micro RNA) from baseline (time frame: baseline and at 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2015.