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Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases

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ClinicalTrials.gov Identifier: NCT02179372
Recruitment Status : Completed
First Posted : July 1, 2014
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
andrea belluzzi, MD phD, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Crohn's Disease Dietary Supplement: Eicosapentaenoic acid Dietary Supplement: Medium chain fatty acid (placebo) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modulation of Fecal Calprotectin by Eicosapentaenoic Free Fatty Acid in Inflammatory Bowel Diseases
Study Start Date : June 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016


Arm Intervention/treatment
Experimental: Eicosapentaenoic acid
Subject with Cronn's Disease and/or Ulcerative colitis in clinical remission will receive 2 g/day of eicosapentaenoic acid for 6 months
Dietary Supplement: Eicosapentaenoic acid
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.
Other Name: ALFA TM (S.L.A. Pharma A.G. Switzerland)

Placebo Comparator: Medium chain fatty acid (placebo)
Subjects with Crohn's Disease and/or Ulcerative colitis will be receive 2 g/day of medium chain fatty acid for 6 months
Dietary Supplement: Medium chain fatty acid (placebo)
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 Measures :
  1. changes in fecal calprotectin levels [ Time Frame: baseline, 3 months and at 6 months ]

Secondary Outcome Measures :
  1. number of clinical flares of diseases [ Time Frame: at 6 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179372


Locations
Italy
Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi
Bologna, Italy, 40138
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: andrea belluzzi, MD phD, Consultant in Gastroenterology, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT02179372     History of Changes
Other Study ID Numbers: EPA/CALPRO
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases