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

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

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 random...

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Main Authors: 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
Format: Article
Language:English
Published: Nature Portfolio 2025-07-01
Series:Nature Communications
Online Access:https://doi.org/10.1038/s41467-025-60755-9
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Summary: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.
ISSN:2041-1723

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