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

Kadalraja Raghavan; Vidyasagar Devaprasad Dedeepiya; Subramaniam Srinivasan; Subramanian Pushkala; Sudhakar S Bharatidasan; Nobunao Ikewaki; Masaru Iwasaki; Rajappa Senthilkumar; Senthilkumar Preethy; Samuel J K Abraham

doi:10.1016/j.ibneur.2023.06.007

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

IBRO Neurosci Rep. 2023 Jul 4:15:90-99. doi: 10.1016/j.ibneur.2023.06.007. eCollection 2023 Dec.

Authors

Affiliations

¹ Dept of Paediatric Neurology, Jesuit Antonyraj memorial Inter-disciplinary Centre for Advanced Recovery and Education (JAICARE), Madurai, India.
² Department of Paediatric Neurology, Kenmax Medical Service Private Limited, Madurai, India.
³ Department of Paediatric Neurology, Sarvee Integra Private Limited, Chennai, India.
⁴ Mary-Yoshio Translational Hexagon (MYTH), Nichi-In Centre for Regenerative Medicine (NCRM), Chennai, India.
⁵ Department of Immunology, The Tamil Nadu Dr. M.G.R. Medical University, Chennai 600032, India.
⁶ Department of Anesthesia, Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, Canada.
⁷ Dept. of Medical Life Science, Kyushu University of Health and Welfare, Japan.
⁸ Institute of Immunology, Junsei Educational Institute, Nobeoka, Miyazaki, Japan.
⁹ Centre for Advancing Clinical Research (CACR), University of Yamanashi - School of Medicine, Chuo, Japan.
¹⁰ Fujio-Eiji Academic Terrain (FEAT), Nichi-In Centre for Regenerative Medicine (NCRM), Chennai, India.
¹¹ Antony, Xavier Interdisciplinary Scholastics (AXIS), GN Corporation Co. Ltd., Kofu, Japan.
¹² Levy-Jurgen Transdisciplinary Exploratory (LJTE), Global Niche Corp., Wilmington, DE, USA.

Abstract

Background: This exploratory case-control study is to evaluate the effects of supplementation of Aureobasidium pullulans-N-163 strain produced 1,3-1,- 6 beta glucan in young patients with Duchenne muscular dystrophy (DMD).

Methods: Twenty-seven male subjects aged 5-19 years with DMD were included, nine in the control arm and 18 in the treatment arm to receive N-163 beta glucan along with conventional therapies for 45 days. While performing the analysis, steroid usage was also taken into consideration, those not administered steroids (Steroid -ve) (Control, n = 5; treatment, n = 9), those administered steroids (Steroid +ve) (Control, n = 4; treatment, n = 9).

Results: IL-6 showed a significant decrease in the treatment groups, especially the N-163 Steroid -ve group. IL-13 decreased in both treatment groups and TGF-β levels showed a significant decrease in the treatment groups, especially the N-163 Steroid -ve group, (p < 0.05). Dystrophin levels increased by up to 32% in the treatment groups compared to the control. Medical research council (MRC) grading showed slight improvement in muscle strength improvement in 12 out of 18 patients (67%) in the treatment group and four out of nine (44%) subjects in the control group.

Conclusion: Supplementation with the N-163 beta glucan food supplement produced beneficial effects: a significant decrease in inflammation and fibrosis markers, increase in serum dystrophin and slight improvement in muscle strength in DMD subjects over 45 days, thus making this a potential adjunct treatment for DMD after validation.

Trial registration: The study was registered in Clinical trials registry of India, CTRI/2021/05/033346. Registered on 5th May, 2021.

Keywords: Beta glucan; Disease modifying agent; Duchenne muscular dystrophy; Dystrophin; Fibrosis; Inflammation; N-163.