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Completed

NCT Number: NCT02179372

Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi

Bologna, 40138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eicosapentaenoic acid

Dietary Supplement

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)

Medium chain fatty acid (placebo)

Dietary Supplement

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 outcomes

  1. changes in fecal calprotectin levels

    Time frame: baseline, 3 months and at 6 months

Secondary outcomes

  1. number of clinical flares of diseases

    Time frame: at 6 months

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 1, 2014
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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