Profermin is efficacious in patients with active ulcerative colitis--a randomized controlled trial

Area of Science:

• Gastroenterology
• Microbiome Research
• Clinical Nutrition

Background:

• Ulcerative colitis (UC) is a chronic inflammatory bowel disease requiring effective dietary management.
• Profermin, a supplement containing fermented oats, barley malt, lecithin, and Lactobacillus plantarum 299v, is designed for the dietary management of UC.

Purpose of the Study:

• To assess the clinical efficacy of Profermin in patients with mild-to-moderate ulcerative colitis flare-ups.
• To compare the reduction in Simple Clinical Colitis Activity Index (SCCAI) scores between Profermin and Fresubin.

Main Methods:

• A randomized controlled trial involving 74 patients with mild-to-moderate UC (SCCAI score ≥5 and ≤11).
• Patients were assigned to receive either Profermin (n=32) or Fresubin (n=41) for 8 weeks.
• The primary endpoint was the significant reduction in SCCAI scores.

Main Results:

• Profermin group showed a significantly higher mean reduction in SCCAI scores (-1.77) compared to the Fresubin group (P < 0.005).
• Remission (SCCAI ≤2.5) was achieved in 31% of the Profermin group versus 15% in the Fresubin group (P = 0.048).
• A ≥50% decrease in SCCAI scores was observed in 53% of the Profermin group versus 27% in the Fresubin group (P = 0.04), with lower dropout rates due to treatment failure in the Profermin group.

Conclusions:

• Profermin supplementation is safe, well-tolerated, and palatable for patients with mild-to-moderate UC flare-ups.
• Profermin effectively reduces SCCAI scores at statistically and clinically significant levels.
• Profermin demonstrates superior efficacy compared to Fresubin in managing UC activity during flare-ups.