Back to resultsEicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases
Primary Purpose
Ulcerative Colitis, Crohn's Disease
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Eicosapentaenoic acid
Medium chain fatty acid (placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
- Age ranged between18 and 80 years.
- Patients with Ulcerative Colitis (diagnosed on the base of clinic, endoscopic and histologic criteria) in clinical remission (SCCAI = 0) from at least 3 months and in stable therapy (without therapeutic modifications in the three previous months) with 5-ASA, immunomodulators and/or biologics.
- Patients affected by Crohn's Disease (diagnosed on the base of clinic, endoscopic and histologic criteria) ) in clinical remission (CDAI < 150) from at least 3 months and in stable therapy (without therapeutic modifications in the three previous months) with 5-ASA, immunomodulators and/or biologics.
- Fecal calprotectin at baseline > 150 μg/g.
Exclusion Criteria:
- Patients affected by Ulcerative Colitis and Crohn's Disease respectively with a SCCAI ≥ 1 and a CDAI ≥150.
- Patients on steroid therapy.
- Patients in therapy wih warfarin or other anticoagulants.
- Known or supposed ipersensitivity to eicosapentaenoic acid/omega 3.
- Women in fertile age which refuse to use contracceptives specified in the study (oral contraception, IUD) and breastfeed women.
- Patients with severe clinical conditions which the investigator consider to controindicate patient partecipation at the study.
- Therapy modifications and/or assumption of sperimental therapies within three months before the study inclusion.
- Patients unable to follow protocol procedures and to sign the informate consent.
Sites / Locations
- Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Eicosapentaenoic acid
Medium chain fatty acid (placebo)
Arm Description
Subject with Cronn's Disease and/or Ulcerative colitis in clinical remission will receive 2 g/day of eicosapentaenoic acid for 6 months
Subjects with Crohn's Disease and/or Ulcerative colitis will be receive 2 g/day of medium chain fatty acid for 6 months
Outcomes
Primary Outcome Measures
changes in fecal calprotectin levels
Secondary Outcome Measures
number of clinical flares of diseases
Full Information
NCT ID
NCT02179372
First Posted
June 29, 2014
Last Updated
November 28, 2016
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT02179372
Brief Title
Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases
Official Title
Modulation of Fecal Calprotectin by Eicosapentaenoic Free Fatty Acid in Inflammatory Bowel Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
November 2016 (Actual)
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 free fatty acid's effects on calprotectin levels in IBD patients in clinical remission. During the study fecal calprotectin levels will be measured every 3 months and clinical flares will be registered.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eicosapentaenoic acid
Arm Type
Experimental
Arm Description
Subject with Cronn's Disease and/or Ulcerative colitis in clinical remission will receive 2 g/day of eicosapentaenoic acid for 6 months
Arm Title
Medium chain fatty acid (placebo)
Arm Type
Placebo Comparator
Arm Description
Subjects with Crohn's Disease and/or Ulcerative colitis will be receive 2 g/day of medium chain fatty acid for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Eicosapentaenoic acid
Other Intervention Name(s)
ALFA TM (S.L.A. Pharma A.G. Switzerland)
Intervention Description
30 subject with Crohn's Disease and/or Ulcerative Colitis in clinical remission but with fecal calprotectin value >150 μg/g will recive 2 g/day of Eicosapentaenoic acid for 6 months treatment. At 3 months and 6 months, fecal calprotectin and clinical activity (CDAI for Crohn's Disease and SCCAI for Ulcerative Colitis) will be measured. The effect of Eicosapentaenoic acid on fecal calprotectin level will be monitored. Clinical relapses will be considered during the study.
Intervention Type
Dietary Supplement
Intervention Name(s)
Medium chain fatty acid (placebo)
Intervention Description
30 subject with Crohn's Disease and/or Ulcerative Colitis in clinical remission but with fecal calprotectin value >150 μg/g will recive 2 g/day of medium chain fatty acids for 6 months treatment. At 3 months and 6 months, fecal calprotectin and clinical activity (CDAI for Crohn's Disease and SCCAI for Ulcerative Colitis) will be measured.
Primary Outcome Measure Information:
Title
changes in fecal calprotectin levels
Time Frame
baseline, 3 months and at 6 months
Secondary Outcome Measure Information:
Title
number of clinical flares of diseases
Time Frame
at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ranged between18 and 80 years.
Patients with Ulcerative Colitis (diagnosed on the base of clinic, endoscopic and histologic criteria) in clinical remission (SCCAI = 0) from at least 3 months and in stable therapy (without therapeutic modifications in the three previous months) with 5-ASA, immunomodulators and/or biologics.
Patients affected by Crohn's Disease (diagnosed on the base of clinic, endoscopic and histologic criteria) ) in clinical remission (CDAI < 150) from at least 3 months and in stable therapy (without therapeutic modifications in the three previous months) with 5-ASA, immunomodulators and/or biologics.
Fecal calprotectin at baseline > 150 μg/g.
Exclusion Criteria:
Patients affected by Ulcerative Colitis and Crohn's Disease respectively with a SCCAI ≥ 1 and a CDAI ≥150.
Patients on steroid therapy.
Patients in therapy wih warfarin or other anticoagulants.
Known or supposed ipersensitivity to eicosapentaenoic acid/omega 3.
Women in fertile age which refuse to use contracceptives specified in the study (oral contraception, IUD) and breastfeed women.
Patients with severe clinical conditions which the investigator consider to controindicate patient partecipation at the study.
Therapy modifications and/or assumption of sperimental therapies within three months before the study inclusion.
Patients unable to follow protocol procedures and to sign the informate consent.
Facility Information:
Facility Name
Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
29391271
Citation
Scaioli E, Sartini A, Bellanova M, Campieri M, Festi D, Bazzoli F, Belluzzi A. Eicosapentaenoic Acid Reduces Fecal Levels of Calprotectin and Prevents Relapse in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1268-1275.e2. doi: 10.1016/j.cgh.2018.01.036. Epub 2018 Jan 31.
Results Reference
derived
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Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases
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