Randomised trial of<i>Aureobasidium pullulans</i>-produced beta 1,3-1,6-glucans in patients with Duchenne muscular dystrophy: Favourable changes in gut microbiota and clinical outcomes indicating their potential in epigenetic manipulation

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<jats:title>Abstract</jats:title><jats:sec><jats:title>Objective</jats:title><jats:p>Duchenne muscular dystrophy (DMD) is an X-linked neuromuscular disorder that leads to increasing muscle weakening and early death. Steroids, the standard treatment of choice in slowing down disease progression, are plagued with adverse effects. Following anti-inflammatory and anti-fibrotic outcomes of an<jats:italic>Aureobasidium pullulans</jats:italic>strain N-163-produced beta 1,3-1,6-glucan food supplement in clinical and pre-clinical studies of DMD, herein we report their implications on the gut microbiome in patients with DMD.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Twenty-seven patients with DMD were included in the pilot study (Control [n=9], N-163 [n=18]) which had previously reported the clinical decrease in inflammatory and fibrosis biomarkers. For the current study, whole genome metagenomic sequencing was performed in pre- and post N-163 intervention faecal samples of each of these participants.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>After N-163 beta-glucan administration, the constitution of the gut microbiome in all the participants was modified to one with positive outcomes on health. There was an increase in butyrate-producing species such as<jats:italic>Roseburia</jats:italic>and<jats:italic>Faecalibacterium prausnitzii</jats:italic>. There was a decrease in harmful bacteria associated with inflammation such as enterobacteria and<jats:italic>Alistipes</jats:italic>.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Beneficial reconstitution of the gut microbiome after N-163 beta-glucan administration, in addition to their implications in anti-inflammatory and anti-fibrotic outcomes, require further in-depth exploration on their roles in epigenetic manipulation.</jats:p></jats:sec>

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