The Effects of a Novel Supplement Containing Probiotics and Vitamin D as an Adjutant Therapy on sNFL and Th Cell Profiles in Patients with Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Trial

IF 2.7 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Alireza Zali, Saba Sadeghi Rashed, Seyedeh Nikan Nejat, Nahid Beladi Moghadam, Javad Arasteh, Saba Taheri, Mehri Salari, Amir M Mortazavian, Mehran Ghaffari, Maryam Tajabadi Ebrahimi
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Abstract

Purpose

multiple sclerosis is a chronic autoimmune disease that affects the central nervous system. It damages the myelin sheath that covers nerve fibers, resulting in neurological symptoms, including muscle weakness, vision problems, and difficulty with coordination and balance. Probiotic bacteria have been shown to have a potential role in managing multiple sclerosis by modulating the immune system and reducing inflammation. They modulate the immune system by increasing the production of anti-inflammatory cytokines, including IL-10, TGF-β, and IL-4, and reducing the levels of pro-inflammatory cytokines, such as IFN-γ and IL-17. Probiotics may also improve gut barrier function, which can help prevent the entry of harmful substances into the bloodstream that could trigger an immune response.

Methods

The presented double-blind, placebo-control clinical trial was conducted to investigate the effect of a novel supplement containing probiotics and vitamin D, so IL-10, TGF-b, IL-4, IL-17, and IFN-gamma cytokines, and neurofilament light chain biomarker were measured by ELISA. Also, we determined the EDSS score and quality of life for patients.

Results

the results revealed that consuming the supplement for twelve weeks can significantly reduce the concentration of NFL biomarker compared to the control group. For the first time, these valuable results demonstrate the effect of probiotic bacteria on reducing this biomarker. Also, the results showed a significant decrease in IL-17 and IFN-γ and modulatory effects on IL-4 and TGF-β. On the other hand, a considerable rise is demonstrated in the IL-10 level.

Conclusion

These findings could provide the supplement as a novel co-therapeutic strategy for multiple sclerosis.

Abstract Image

一种含有益生菌和维生素D的新型补充剂作为辅助治疗对多发性硬化患者sNFL和Th细胞谱的影响:一项随机、双盲、安慰剂对照试验
目的多发性硬化症是一种影响中枢神经系统的慢性自身免疫性疾病。它会损害覆盖神经纤维的髓鞘,导致神经系统症状,包括肌肉无力、视力问题、协调和平衡困难。益生菌已被证明在通过调节免疫系统和减少炎症来治疗多发性硬化症方面具有潜在的作用。它们通过增加抗炎细胞因子的产生来调节免疫系统,包括IL-10、TGF-β和IL-4,并降低促炎细胞因子的水平,如IFN-γ和IL-17。益生菌还可以改善肠道屏障功能,这有助于防止有害物质进入血液,从而引发免疫反应。方法采用双盲、安慰剂对照临床试验,采用ELISA法检测IL-10、TGF-b、IL-4、IL-17、ifn - γ细胞因子及神经丝轻链生物标志物的影响。此外,我们确定了患者的EDSS评分和生活质量。结果结果显示,与对照组相比,服用补充剂12周可显著降低NFL生物标志物的浓度。这些有价值的结果首次证明了益生菌对降低这一生物标志物的作用。同时,IL-17和IFN-γ显著降低,对IL-4和TGF-β有调节作用。另一方面,IL-10水平有相当大的上升。结论该制剂可作为多发性硬化症的一种新的联合治疗策略。
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来源期刊
Journal of Pharmaceutical Innovation
Journal of Pharmaceutical Innovation PHARMACOLOGY & PHARMACY-
CiteScore
3.70
自引率
3.80%
发文量
90
审稿时长
>12 weeks
期刊介绍: The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories: Materials science, Product design, Process design, optimization, automation and control, Facilities; Information management, Regulatory policy and strategy, Supply chain developments , Education and professional development, Journal of Pharmaceutical Innovation publishes four issues a year.
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