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The effects of probiotics supplementation on serum markers of oxidative stress in relapsing-remitting multiple sclerosis: a randomised, double-blind, placebo-controlled clinical trial

in Beneficial Microbes
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N. Mohy Neurosciences Research Center (NSRC), Imam Reza General Hospital, Tabriz University of Medical Sciences, Tabriz, Iran

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https://orcid.org/0009-0002-8952-6764
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S. Sanaie Research Center for Integrative Medicine in Aging, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran

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https://orcid.org/0000-0003-2325-5631
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S. Rahnemayan Neurosciences Research Center (NSRC), Imam Reza General Hospital, Tabriz University of Medical Sciences, Tabriz, Iran

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https://orcid.org/0000-0003-0641-4178
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M. Yousefi Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran

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https://orcid.org/0000-0003-0099-6728
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M. Talebi Neurosciences Research Center (NSRC), Imam Reza General Hospital, Tabriz University of Medical Sciences, Tabriz, Iran

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https://orcid.org/0000-0002-7613-3913
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A. Naseri Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran
Research Center for Evidence-Based Medicine, Iranian EBM Center: A Joanna Briggs Institute Center of Excellence, Tabriz University of Medical Sciences, Tabriz, Iran
Tabriz USERN Office, Universal Scientific Education and Research Network (USERN), Tabriz, Iran

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https://orcid.org/0000-0001-9723-0109
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Abstract

Oxidative stress is a significant contributor to neuronal damage in multiple sclerosis (MS), marked by an imbalance in reactive oxygen species and antioxidant defences. Probiotics may modulate oxidative stress and improve antioxidant levels. This double-blind, randomised, placebo-controlled clinical trial aimed to evaluate the effects of probiotics supplementation on serum oxidative stress markers and endogenous antioxidants in patients with relapsing-remitting MS (RRMS). Ninety RRMS patients with expanded disability status scale [EDSS] < 4 were randomised into two groups: a probiotics group (Lactocare®) and a placebo group, and received the interventions twice daily for four months. Serum levels of oxidative stress markers (malondialdehyde [MDA]), endogenous antioxidants (glutathione peroxidase [GPx] activity, superoxide dismutase [SOD], catalase activity [CAT], glutathione [GSH]), and total antioxidant capacity (TAC) were measured at baseline and post-treatment. Fifty-five patients, including 26 patients in the probiotic group and 29 patients in the placebo group, completed the study. Both groups showed significant within-group improvements in GPx activity, SOD, and GSH levels, as well as reductions in MDA levels ( P < 0.05); however, no significant between-group differences were found for any markers ( P > 0.05). TAC and CAT levels remained unchanged in both groups. Findings of this study did not support the evidence for antioxidant effects of probiotics supplementation in RRMS patients, and its effects on oxidative stress markers in RRMS patients are found to be comparable to placebo.

Iranian Registry of Clinical Trials: IRCT20220713055465N2, registration date: 2023.5.9

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