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<p>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&#xa0;thereby&#xa0; 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® (<i>n</i> = 28) or standard nutritional support (Fresubin®, <i>n</i> = 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&#xa0;using automated digital imaging analysis. Paired liver biopsies meeting quality criteria for the primary outcome were available for 40 participants (ReFerm®, <i>n</i> = 21 and Fresubin®, <i>n</i> = 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; <i>p</i> = 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.</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月1日

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  • Johanne K. Hansen,
  • Mads Israelsen,
  • Suguru Nishijima,
  • Sara E. Stinson,
  • Peter Andersen,
  • Stine Johansen,
  • Camilla D. Hansen,
  • Maximilian Joseph Brol,
  • Sabine Klein,
  • Robert Schierwagen,
  • Frank Erhard Uschner,
  • Karolina Sulek,
  • Ida F. Villesen,
  • Katrine P. Lindvig,
  • Katrine H. Thorhauge,
  • Nikolaj Torp,
  • Jane M. Jensen,
  • Marisa Isabell Keller,
  • Gitte H. Jensen,
  • Sönke Detlefsen,
  • Diana J. Leeming,
  • Evelina Stankevic,
  • Tommi Suvitaival,
  • Andressa Zawadzki,
  • Michael Kuhn,
  • Lars Juhl Jensen,
  • Morten Karsdal,
  • Jonel Trebicka,
  • Hans Israelsen,
  • Cristina Legido-Quigley,
  • Peer Bork,
  • Manimozhiyan Arumugam,
  • Torben Hansen,
  • Maja Thiele,
  • Aleksander Krag

摘要

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.