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| Item Type: | Article |
|---|---|
| Title: | The postbiotic ReFerm versus standard nutritional support in advanced alcohol-related liver disease (GALA-POSTBIO): a randomized controlled phase 2 trial |
| Creators Name: | Hansen, J.K., Israelsen, M., Nishijima, S., Stinson, S.E., Andersen, P., Johansen, S., Hansen, C.D., Brol, M.J., Klein, S., Schierwagen, R., Uschner, F.E., Sulek, K., Villesen, I.F., Lindvig, K.P., Thorhauge, K.H., Torp, N., Jensen, J.M., Keller, M.I., Jensen, G.H., Detlefsen, S., Leeming, D.J., Stankevic, E., Suvitaival, T., Zawadzki, A., Kuhn, M., Jensen, L.J., Karsdal, M., Trebicka, J., Israelsen, H., Legido-Quigley, C., Bork, P., Arumugam, M., Hansen, T., Thiele, M. and Krag, A. |
| 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. |
| Keywords: | Alcoholic Liver Diseases, Liver, Liver Cirrhosis, Nutritional Support, Treatment Outcome |
| Source: | Nature Communications |
| ISSN: | 2041-1723 |
| Publisher: | Nature Publishing Group |
| Volume: | 16 |
| Number: | 1 |
| Page Range: | 5969 |
| Date: | 1 July 2025 |
| Official Publication: | https://doi.org/10.1038/s41467-025-60755-9 |
| PubMed: | View item in PubMed |
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