A postbiotic fermented oat gruel may have a beneficial effect on the colonic mucosal barrier in patients with irritable bowel syndrome.

Background: Impaired intestinal permeability and microbial dysbiosis are important pathophysiological mechanisms underlying irritable bowel syndrome (IBS). ReFerm®, also called Profermin®, is a postbiotic product of oat gruel fermented with Lactobacillus plantarum 299v. In this study, we investigated whether ReFerm® has a beneficial effect on the intestinal epithelial barrier function in patients with IBS. Materials and methods: Thirty patients with moderate to severe IBS-diarrhoea (IBS-D) or IBS-mixed (IBS-M) were treated with enema containing ReFerm® or placebo. The patients underwent sigmoidoscopy with biopsies obtained from the distal colon at baseline and after 14 days of treatment with ReFerm® or placebo twice daily. The biopsies were mounted in Ussing chambers, and paracellular and transcellular permeabilities were measured for 120 min. In addition, the effects of ReFerm® or placebo on the epithelial barrier were investigated in vitro using Caco-2 cells. Results: ReFerm® reduced paracellular permeability (p < 0.05) and increased transepithelial resistance (TER) over time (p < 0.01), whereas the placebo had no significant effect in patients. In ReFerm®-treated Caco-2 cells, paracellular and transcellular permeabilities were decreased compared to the control (p < 0.05) and placebo (p < 0.01). TER was increased in Caco-2 ReFerm®-treated cells, and normalised TER was increased in ReFerm®-treated Caco-2 cells compared to control (p < 0.05) and placebo-treated (p < 0.05) cells. Conclusion: ReFerm® significantly reduced paracellular permeability and improved TER in colonic biopsies collected from patients with IBS and in a Caco-2 cell model. Our results offer new insights into the potential benefits of ReFerm® in IBS management. Further studies are needed to identify the molecular mechanisms underlying the barrier-protective properties of ReFerm®. Clinical trial registration: [https://clinicaltrials.gov/], identifier [NCT05475314].

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

BACKGROUND: Profermin is developed for the dietary management of ulcerative colitis (UC). It consists of water, fermented oats, barley malt, lecithin, and Lactobacillus plantarum 299v. The aim of this study was to assess the clinical efficacy of Profermin. METHODS: Seventy-four patients with a mild-to-moderate flare-up of UC (defined as Simple Clinical Colitis Activity Index [SCCAI] score ≥5 and ≤11) were randomly assigned to Profermin (n = 32) or Fresubin (n = 41). The primary endpoint was to assess whether addition of Profermin in UC could significantly reduce SCCAI in comparison with Fresubin. RESULTS: In the run-in period, the mean SCCAI was 7.2 ± 1.50 in the Profermin group and 7.6 ± 1.47 in the Fresubin group (not significant). After 8 weeks of treatment, the mean reduction of SCCAI score was higher in the Profermin group (mean difference: -1.77 SCCAI, 95% confidence interval -2.97 to -0.55; P < 0.005), in intention-to-treat analyses. Remission defined as SCCAI ≤2.5 was achieved in 10 of 32 (31%) in the Profermin group and in 6 of 41 (15%) in the Fresubin group (P = 0.048). The decrease in SCCAI scores of ≥50% was higher in the Profermin group 17 of 32 (53%) versus 11 of 41 (27%) (P = 0.04). The risk of dropping out due to treatment failure/lack of effect was higher in the Fresubin group (42% versus 13%, P = 0.02). CONCLUSIONS: Supplementation with Profermin is safe, well tolerated, palatable, and able to reduce SCCAI scores at a statistically and clinically significant level in patients with mild-to-moderate UC with a flare-up.

Safety and efficacy of Profermin® to induce remission in ulcerative colitis.

AIM: To test the efficacy and safety of Profermin(®) in inducing remission in patients with active ulcerative colitis (UC). METHODS: The study included 39 patients with mild to moderate UC defined as a Simple Clinical Colitis Activity Index (SCCAI) > 4 and < 12 (median: 7.5), who were treated open-label with Profermin(®) twice daily for 24 wk. Daily SCCAI was reported observer blinded via the Internet. RESULTS: In an intention to treat (ITT) analysis, the mean reduction in SCCAI score was 56.5%. Of the 39 patients, 24 (62%) reached the primary endpoint, which was proportion of patients with ≥ 50% reduction in SCCAI. Our secondary endpoint, the proportion of patients in remission defined as SCCAI ≤ 2.5, was in ITT analysis reached in 18 of the 39 patients (46%). In a repeated-measure regression analysis, the estimated mean reduction in score was 5.0 points (95% CI: 4.1-5.9, P < 0.001) and the estimated mean time taken to obtain half the reduction in score was 28 d (95% CI: 26-30). There were no serious adverse events (AEs) or withdrawals due to AEs. Profermin(®) was generally well tolerated. CONCLUSION: Profermin(®) is safe and may be effective in inducing remission of active UC.