Beneficial immune-modulatory effects of the N-163 strain of Aureobasidium pullulans-produced 1,3-1,6 Beta glucans in Duchenne muscular dystrophy: Results of an open-label, prospective, exploratory case-control clinical study

BackgroundThis exploratory case-control study is to evaluate the effects of supplementation Aureobasidium pullulans-N-163 strain produced 1,3-1,-6 beta glucan in young patients with Duchenne muscular dystrophy (DMD).MethodsTwenty-seven male subjects aged 5-19 years DMD were included, nine control arm and 18 treatment receive N-163 along conventional therapies for 45 days. While performing analysis, steroid usage was also taken into consideration, those not administered steroids (Steroid -ve) (Control, n=5; treatment, n=9), +ve) n=4; n=9).ResultsIL-6 showed a significant decrease groups, especially Steroid -ve group. IL-13 decreased both groups TGF-β levels –ve group, (p <0.05). Dystrophin increased by up 32% compared control. Medical research council (MRC) grading slight improvement muscle strength 12 out (67%) group four (44%) group.ConclusionSupplementation food supplement beneficial effects: inflammation fibrosis markers, increase serum dystrophin over days, thus making this potential adjunct after validation.Trial registrationThe registered Clinical trials registry India, CTRI/2021/05/033346. Registered on 5th May, 2021.