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The postbiotic ReFerm® versus standard nutritional support in advanced alcohol-related liver disease (GALA-POSTBIO): a randomized controlled phase 2 trial.
Hansen JK, Israelsen M,
Nishijima S, Stinson SE, Andersen P, Johansen S, Hansen CD, Brol MJ, Klein S, Schierwagen R, Uschner FE, Sulek K, Villesen IF, Lindvig KP, Thorhauge KH, Torp N, Jensen JM,
Keller MI, Jensen GH, Detlefsen S, Leeming DJ, Stankevic E, Suvitaival T, Zawadzki A,
Kuhn M,
Jensen LJ, Karsdal M, Trebicka J, Israelsen H, Legido-Quigley C,
Bork P,
Arumugam M, Hansen T, Thiele M, Krag A
Impaired gut barrier function may lead to progression of liver fibrosis in people with alcohol-related liver disease. The postbiotic ReFerm® can lower gut barrier permeability and may thereby reduce fibrosis formation. Here, we report the results from an open-labelled, single centre randomized controlled trial where 56 patients with advanced, compensated, alcohol-related liver disease were assigned 1:1 to receive either ReFerm® (n = 28) or standard nutritional support (Fresubin®, n = 28) for 24 weeks. The primary outcome was a ≥ 10% reduction of the fibrosis formation marker alpha-smooth muscle actin in liver biopsies, assessed by a blinded pathologist using automated digital imaging analysis. Paired liver biopsies meeting quality criteria for the primary outcome were available for 40 participants (ReFerm®, n = 21 and Fresubin®, n = 19). This reduction was observed in 29% of patients receiving ReFerm®, compared to 14% with Fresubin® (OR = 2.40; 95% CI 0.63 to 9.16; p = 0.200). No treatment-related serious adverse events occurred. Our findings suggest that ReFerm® may reduce liver fibrosis by enhancing gut barrier function, potentially preventing the progression of alcohol-related liver disease.
Abstract