The postbiotic ReFerm® versus standard nutritional support in advanced alcohol-related liver disease (GALA-POSTBIO): a randomized controlled phase 2 trial

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 and Aleksander Krag ()
Additional contact information
Johanne K. Hansen: Odense University Hospital
Mads Israelsen: Odense University Hospital
Suguru Nishijima: European Molecular Biology Laboratory
Sara E. Stinson: University of Copenhagen
Peter Andersen: Odense University Hospital
Stine Johansen: Odense University Hospital
Camilla D. Hansen: Odense University Hospital
Maximilian Joseph Brol: University of Münster
Sabine Klein: University of Münster
Robert Schierwagen: University of Münster
Frank Erhard Uschner: University of Münster
Karolina Sulek: Steno Diabetes Center Copenhagen
Ida F. Villesen: Odense University Hospital
Katrine P. Lindvig: Odense University Hospital
Katrine H. Thorhauge: Odense University Hospital
Nikolaj Torp: Odense University Hospital
Jane M. Jensen: Odense University Hospital
Marisa Isabell Keller: European Molecular Biology Laboratory
Gitte H. Jensen: Odense University Hospital
Sönke Detlefsen: University of Southern Denmark
Diana J. Leeming: Nordic Bioscience A/S, Biomarkers & Research
Evelina Stankevic: University of Copenhagen
Tommi Suvitaival: Steno Diabetes Center Copenhagen
Andressa Zawadzki: Steno Diabetes Center Copenhagen
Michael Kuhn: European Molecular Biology Laboratory
Lars Juhl Jensen: University of Copenhagen
Morten Karsdal: Nordic Bioscience A/S, Biomarkers & Research
Jonel Trebicka: Odense University Hospital
Hans Israelsen: Nordic Rebalance A/S
Cristina Legido-Quigley: Steno Diabetes Center Copenhagen
Peer Bork: European Molecular Biology Laboratory
Manimozhiyan Arumugam: Odense University Hospital
Torben Hansen: University of Copenhagen
Maja Thiele: Odense University Hospital
Aleksander Krag: Odense University Hospital

Nature Communications, 2025, vol. 16, issue 1, 1-16

Abstract: Abstract 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.

Date: 2025
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DOI: 10.1038/s41467-025-60755-9

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