Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases

November 28, 2016 updated by: andrea belluzzi, MD phD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Modulation of Fecal Calprotectin by Eicosapentaenoic Free Fatty Acid in Inflammatory Bowel Diseases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in fecal calprotectin levels
Time Frame: baseline, 3 months and at 6 months
baseline, 3 months and at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
number of clinical flares of diseases
Time Frame: at 6 months
at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

June 29, 2014

First Submitted That Met QC Criteria

June 29, 2014

First Posted (ESTIMATE)

July 1, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 29, 2016

Last Update Submitted That Met QC Criteria

November 28, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPA/CALPRO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn's Disease

Clinical Trials on Eicosapentaenoic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe