Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases

NCT02179372 | Completed

• 1 other identifier: EPA/CALPRO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• changes in fecal calprotectin levels

  baseline, 3 months and at 6 months

Secondary Outcomes (1)

• number of clinical flares of diseases

  at 6 months

Study Arms (2)

Eicosapentaenoic acid

EXPERIMENTAL

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

Medium chain fatty acid (placebo)

PLACEBO COMPARATOR

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)

Interventions

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.

Also known as: ALFA TM (S.L.A. Pharma A.G. Switzerland)

Eicosapentaenoic acid

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.

Medium chain fatty acid (placebo)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients unable to follow protocol procedures and to sign the informate consent.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi

Bologna, Bologna, 40138, Italy

Location

Related Publications (1)

• 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.

  PMID: 29391271 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Interventions

Eicosapentaenoic Acid

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Gastroenterology

Study Record Dates

• First Submitted: June 29, 2014
• First Posted: July 1, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 29, 2016

Record last verified: 2016-11

Locations

IT (1)