The Effects of Probiotic Supplementation on Level of Disability, Depressive Symptoms, and Cognitive Outcomes in Relapsing-Remitting Multiple Sclerosis Patients: A Randomized Double-Blind Placebo-Controlled Trial
Background: Multiple sclerosis (MS) is a chronic autoimmune disease characterized by inflammation and demyelination of the central nervous system. Probiotics, through the gut-brain axis, are suggested to enhance clinical outcomes in patients with MS. This study scrutinizes the effects of probiotic s...
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Tabriz University of Medical Sciences
2025-07-01
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| Series: | Pharmaceutical Sciences |
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| Online Access: | https://ps.tbzmed.ac.ir/PDF/ps-31-322.pdf |
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| author | Amirreza Naseri Sarvin Sanaie Sama Rahnemayan Reza Mosaddeghi-Heris Malihe Talebi Mahnaz Talebi |
| author_facet | Amirreza Naseri Sarvin Sanaie Sama Rahnemayan Reza Mosaddeghi-Heris Malihe Talebi Mahnaz Talebi |
| author_sort | Amirreza Naseri |
| collection | DOAJ |
| description | Background: Multiple sclerosis (MS) is a chronic autoimmune disease characterized by inflammation and demyelination of the central nervous system. Probiotics, through the gut-brain axis, are suggested to enhance clinical outcomes in patients with MS. This study scrutinizes the effects of probiotic supplementation in relapsing-remitting MS (RRMS) patients. Methods: In this parallel, randomized, double-blind, placebo-controlled trial, 90 RRMS patients, with Expanded Disability Status Scale (EDSS) < 4, received either the probiotic (Lactocare®) or a placebo twice daily for four months. Assessed outcomes included level of disability (based on EDSS), cognitive function (Symbol Digit Modalities Test [SDMT], three-second version of Paced Auditory Serial Addition Test [PASAT-3]), depressive symptoms (Beck Depression Inventory- II [BDI-II]), and manual dexterity (Nine-Hole Peg Test [9HPT]). Blinding was performed for outcome assessors and the patients. All assessments were conducted at baseline and after four months, and the findings compared between the groups of the study. Results: Out of 90 randomized patients, 60 completed the trial (29 in the probiotics group, 31 in the placebo group). Probiotics supplementation was not associated with significant improvement in EDSS, BDI-II, PASAT, SDMT, and non-dominant hand 9HPT (p-values > 0.05). Intragroup improvements in PASAT-3 (change median: 2 [IQR:9.5]) and dominant hand 9HPT (change median: -0.43 [IQR: 2.15]) were observed in the probiotic supplementation group, which was comparable to placebo. Conclusion: Supplementation with a seven-strain probiotics product for four months does not result in a significant improvement in depressive symptoms, cognitive performance, level of disability, and manual dexterity of RRMS patients with EDSS < 4. |
| format | Article |
| id | doaj-art-1246fbb34dee4af4a69044cb890b8d74 |
| institution | Kabale University |
| issn | 2383-2886 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Tabriz University of Medical Sciences |
| record_format | Article |
| series | Pharmaceutical Sciences |
| spelling | doaj-art-1246fbb34dee4af4a69044cb890b8d742025-08-20T03:50:39ZengTabriz University of Medical SciencesPharmaceutical Sciences2383-28862025-07-0131332232910.34172/PS.025.41013ps-41013The Effects of Probiotic Supplementation on Level of Disability, Depressive Symptoms, and Cognitive Outcomes in Relapsing-Remitting Multiple Sclerosis Patients: A Randomized Double-Blind Placebo-Controlled TrialAmirreza Naseri0Sarvin Sanaie1Sama Rahnemayan2Reza Mosaddeghi-Heris3Malihe Talebi4Mahnaz Talebi5Student Research Committee, Tabriz University of Medical Sciences, Tabriz, IranNeurosciences Research Center (NSRC), Imam Reza General Hospital, Tabriz University of Medical Sciences, Tabriz, IranNeurosciences Research Center (NSRC), Imam Reza General Hospital, Tabriz University of Medical Sciences, Tabriz, IranNeurosciences Research Center (NSRC), Imam Reza General Hospital, Tabriz University of Medical Sciences, Tabriz, IranNeurosciences Research Center (NSRC), Imam Reza General Hospital, Tabriz University of Medical Sciences, Tabriz, IranNeurosciences Research Center (NSRC), Imam Reza General Hospital, Tabriz University of Medical Sciences, Tabriz, IranBackground: Multiple sclerosis (MS) is a chronic autoimmune disease characterized by inflammation and demyelination of the central nervous system. Probiotics, through the gut-brain axis, are suggested to enhance clinical outcomes in patients with MS. This study scrutinizes the effects of probiotic supplementation in relapsing-remitting MS (RRMS) patients. Methods: In this parallel, randomized, double-blind, placebo-controlled trial, 90 RRMS patients, with Expanded Disability Status Scale (EDSS) < 4, received either the probiotic (Lactocare®) or a placebo twice daily for four months. Assessed outcomes included level of disability (based on EDSS), cognitive function (Symbol Digit Modalities Test [SDMT], three-second version of Paced Auditory Serial Addition Test [PASAT-3]), depressive symptoms (Beck Depression Inventory- II [BDI-II]), and manual dexterity (Nine-Hole Peg Test [9HPT]). Blinding was performed for outcome assessors and the patients. All assessments were conducted at baseline and after four months, and the findings compared between the groups of the study. Results: Out of 90 randomized patients, 60 completed the trial (29 in the probiotics group, 31 in the placebo group). Probiotics supplementation was not associated with significant improvement in EDSS, BDI-II, PASAT, SDMT, and non-dominant hand 9HPT (p-values > 0.05). Intragroup improvements in PASAT-3 (change median: 2 [IQR:9.5]) and dominant hand 9HPT (change median: -0.43 [IQR: 2.15]) were observed in the probiotic supplementation group, which was comparable to placebo. Conclusion: Supplementation with a seven-strain probiotics product for four months does not result in a significant improvement in depressive symptoms, cognitive performance, level of disability, and manual dexterity of RRMS patients with EDSS < 4.https://ps.tbzmed.ac.ir/PDF/ps-31-322.pdfmultiple sclerosisprobioticscognitive functiondepressive symptomsphysical disabilityrandomized controlled trial |
| spellingShingle | Amirreza Naseri Sarvin Sanaie Sama Rahnemayan Reza Mosaddeghi-Heris Malihe Talebi Mahnaz Talebi The Effects of Probiotic Supplementation on Level of Disability, Depressive Symptoms, and Cognitive Outcomes in Relapsing-Remitting Multiple Sclerosis Patients: A Randomized Double-Blind Placebo-Controlled Trial Pharmaceutical Sciences multiple sclerosis probiotics cognitive function depressive symptoms physical disability randomized controlled trial |
| title | The Effects of Probiotic Supplementation on Level of Disability, Depressive Symptoms, and Cognitive Outcomes in Relapsing-Remitting Multiple Sclerosis Patients: A Randomized Double-Blind Placebo-Controlled Trial |
| title_full | The Effects of Probiotic Supplementation on Level of Disability, Depressive Symptoms, and Cognitive Outcomes in Relapsing-Remitting Multiple Sclerosis Patients: A Randomized Double-Blind Placebo-Controlled Trial |
| title_fullStr | The Effects of Probiotic Supplementation on Level of Disability, Depressive Symptoms, and Cognitive Outcomes in Relapsing-Remitting Multiple Sclerosis Patients: A Randomized Double-Blind Placebo-Controlled Trial |
| title_full_unstemmed | The Effects of Probiotic Supplementation on Level of Disability, Depressive Symptoms, and Cognitive Outcomes in Relapsing-Remitting Multiple Sclerosis Patients: A Randomized Double-Blind Placebo-Controlled Trial |
| title_short | The Effects of Probiotic Supplementation on Level of Disability, Depressive Symptoms, and Cognitive Outcomes in Relapsing-Remitting Multiple Sclerosis Patients: A Randomized Double-Blind Placebo-Controlled Trial |
| title_sort | effects of probiotic supplementation on level of disability depressive symptoms and cognitive outcomes in relapsing remitting multiple sclerosis patients a randomized double blind placebo controlled trial |
| topic | multiple sclerosis probiotics cognitive function depressive symptoms physical disability randomized controlled trial |
| url | https://ps.tbzmed.ac.ir/PDF/ps-31-322.pdf |
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