title: An oral supplement enriched with fish oil, soluble fiber, and antioxidants for corticosteroid sparing in ulcerative colitis: a randomized, controlled trial.
abstract: OBJECTIVE
  N-3 fatty acids from fish oil, antioxidants, and short-chain fatty acids (SCFAs) produced during the fermentation of soluble fiber may attenuate inflammation associated with ulcerative colitis (UC). We assessed the efficacy of a nutritionally balanced oral supplement enriched with fish oil, fructooligosaccharides, gum arabic, vitamin E, vitamin C, and selenium on disease activity and medication use in adults with mild to moderate UC.
  
  
  METHODS
  A total of 121 patients with UC and a disease activity index (DAI) from 3-9 on a 12-point scale were block randomized for extent of disease and smoking status. In addition to their usual diet, patients consumed 18 oz of the oral supplement or a carbohydrate-based placebo formula each day for 6 months. Clinical and histologic responses were assessed at 3 and 6 months or at the final visit. A change in average prednisone use between groups was tested by using a linear mixed-effects model.
  
  
  RESULTS
  Eighty-six patients completed the study. Baseline characteristics were not different between groups except for a higher total DAI score in the oral supplement group (7.3 +/- 1.3; n = 36) compared with the placebo group (6.2 +/- 2.0; n = 50) ( P < .05). Both groups showed significant and similar degree of improvement at 6 months in DAI (-2.5 for oral supplement and -2.8 for placebo) and histologic index (-1.9 for oral supplement vs. -2.0 for placebo). Both intent-to-treat and completed patients given oral supplement had a significantly greater rate of decrease in the dose of prednisone required to control clinical symptoms over 6 months as compared with the placebo group ( P < .001).
  
  
  CONCLUSIONS
  The improvement in clinical response combined with a decreased requirement for corticosteroids suggest that this enriched oral supplement can be a useful adjuvant therapy in patients with UC.
authors.affiliation: Department of Gastroenterology\A30, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA. seidned@ccf.org
authors.forename: Douglas L
authors.initials: DL
authors.lastname: Seidner
authors.forename: Bret A
authors.initials: BA
authors.lastname: Lashner
authors.forename: Aaron
authors.initials: A
authors.lastname: Brzezinski
authors.forename: Phillip L C
authors.initials: PL
authors.lastname: Banks
authors.forename: John
authors.initials: J
authors.lastname: Goldblum
authors.forename: Claudio
authors.initials: C
authors.lastname: Fiocchi
authors.forename: Jeffry
authors.initials: J
authors.lastname: Katz
authors.forename: Gary R
authors.initials: GR
authors.lastname: Lichtenstein
authors.forename: Peter A
authors.initials: PA
authors.lastname: Anton
authors.forename: Lori Y
authors.initials: LY
authors.lastname: Kam
authors.forename: Keith A
authors.initials: KA
authors.lastname: Garleb
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Demichele
mesh_terms: D000284:Administration, Oral; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000328:Adult; D000975:Antioxidants / Q000627:therapeutic use*; D001707:Biopsy, Needle; D003093:Colitis, Ulcerative / Q000178:diet therapy* / Q000473:pathology*; D004043:Dietary Fiber / Q000008:administration & dosage*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005395:Fish Oils / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D007150:Immunohistochemistry; D007413:Intestinal Mucosa / Q000473:pathology; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000975:Antioxidants; D004043:Dietary Fiber; D005395:Fish Oils