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.


Background & aims: High fecal levels of calprotectin indicate mucosal inflammation and have been shown to predict relapse in patients with ulcerative colitis (UC). Eicosapentaenoic acid (EPA), the major component of n-3 fish oil, has anti-inflammatory properties in patients with chronic inflammatory disorders. We performed a placebo-controlled trial of patients with UC at risk of relapse to determine the ability of the free fatty acid form of EPA (EPA-FFA) to reduce intestinal inflammation, using fecal level of calprotectin as a marker.

Methods: From June 2014 to May 2016, 60 patients with UC with a partial Mayo score < 2 and fecal calprotectin ≥150 μg/g, in stable therapy for at least the 3 previous months, were randomly assigned to groups (1:1) given either EPA-FFA (500 mg, twice daily) or placebo for 6 months. A colonoscopy was performed at baseline. Clinical assessments and measurements of fecal calprotectin were made at baseline, at study months 3 and 6, or the time of clinical relapse. Patients with a relapse of UC underwent a second colonoscopy. The primary end point was a 100-point reduction in fecal levels of calprotectin at 6 months from the baseline value; the secondary end point was maintenance of clinical remission at 6 months.

Results: The primary end point was achieved by 19 of 30 patients (63.3%) in the EPA-FFA group vs 4 of 30 patients (13.3%) in the placebo group (odds ratio, 12.0; 95% CI, 3.12-46.24; P < .001). The secondary end point was achieved by 23 of 30 patients (76.7%) in the EPA-FFA group vs 15 of 30 (50%) patients in the placebo group (OR, 3.29; 95% CI, 1.08-9.95; P = .035). No serious adverse events were observed.

Conclusions: In a placebo-controlled trial of 60 patients with UC, we found 6 months' administration of EPA-FFA to reduce fecal levels of calprotectin with no serious adverse events. This agent might be used to induce and maintain symptom-free remission in patients with UC. ClinicalTrials.gov number: NCT02179372.

Keywords: FC; IBD; Immune Regulation; Inflammatory Bowel Disease Treatment.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Chemoprevention / methods*
  • Colitis, Ulcerative / drug therapy
  • Colitis, Ulcerative / prevention & control*
  • Colon / pathology
  • Colonoscopy
  • Double-Blind Method
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Drug-Related Side Effects and Adverse Reactions / pathology
  • Eicosapentaenoic Acid / administration & dosage*
  • Eicosapentaenoic Acid / adverse effects
  • Feces / chemistry*
  • Female
  • Humans
  • Intestinal Mucosa / pathology
  • Leukocyte L1 Antigen Complex / analysis*
  • Male
  • Middle Aged
  • Placebos / administration & dosage
  • Secondary Prevention / methods*
  • Treatment Outcome
  • Young Adult


  • Anti-Inflammatory Agents
  • Leukocyte L1 Antigen Complex
  • Placebos
  • Eicosapentaenoic Acid

Associated data

  • ClinicalTrials.gov/NCT02179372