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.
Article first published online 8 October 2013
*Department of Gastroenterology, Odense University Hospital, Odense, Denmark;
†Gastroenterology Unit, Medical Section, Herlev University Hospital, Copenhagen, Denmark;
‡Nordisk Rebalance, Allerød, Denmark;
§Statistics, Bioinformatics and Registry, Danish Cancer Society Research Center, Copenhagen, Denmark; and
‖Gastrounit, Medical Division, Hvidovre University Hospital, Denmark.
Reprints: Aleksander Krag, PhD, Department of Gastroenterology, Odense University Hospital, Sdr. Boulevard 29, Indgang 126, 2. sal, 5000 Odense C, Denmark (e-mail: Aleksander.Krag@rsyd.dk).
This work was partly financed by a Danish Innovation Law Grant (J.nr. 3414-06-01,530) from the Danish Food Industry Agency under the Ministry of Food, Agriculture and Fisheries. Profermin is developed and manufactured by Nordisk Rebalance, who partly financed the study. All authors had full access to all data.
A. Krag has acted as consultant to Nordisk Rebalance. H. Israelsen and B. von Ryberg are employees in Nordisk Rebalance. P. Munkholm, K. K. Andersen, and F. Bendtsen report no conflicts of interests to disclose.
Received August 13, 2013
Accepted August 26, 2013