NCT07346924

Effect of Probiotics on Relapsing-Remitting Multiple Sclerosis

Probiotics as a Promising Adjunct: Improving Fatigue, Quality of Life, Disability, Mood and Inflammatory Markers in Relapsing-Remitting Multiple Sclerosis: A Randomized, Double-blind, Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to assess the effect of probiotic supplementation on fatigue, quality of life, disability, depression and inflammatory markers in patients with relapsing-remitting multiple sclerosis (RRMS). Patients were randomized to receive probiotics plus standard therapy The study sought to determine whether modulation of gut microbiota could provide additional clinical and immunological benefits in RRMS management.

Detailed description

This trial was conducted as part of a Doctoral (PhD) thesis at the Department of Neurology, Cairo University The purpose of the trial was to evaluate the potential effects of probiotic supplementation on clinical and biological outcomes in patients with relapsing-remitting multiple sclerosis (RRMS). Multiple sclerosis is a chronic inflammatory and demyelinating disease of the central nervous system, in which immune dysregulation and gut microbiota imbalance may play a key role. Recent evidence suggests that probiotics could exert beneficial immunomodulatory and anti-inflammatory effects, potentially improving patient outcomes. In this randomized controlled study, patients with RRMS received either probiotic supplementation or standard therapy alone for a defined period. The primary outcomes included changes in fatigue quality of life, disability and depressive symptoms Secondary outcomes included alterations in inflammatory biomarkers such as cytokines and other immune mediators. The results of this study are expected to provide additional insights into the role of gut microbiota modulation as an adjunctive approach in the management of multiple sclerosis. No major protocol deviations occurred, and the study adhered to ethical standards approved by the local ethics committee.

Conditions

• Multiple Sclerosis (MS) Relapsing Remitting

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic dietary supplement	The probiotic group only had regular daily probiotic intake in the form of 2 cups of yogurt rich in probiotics - each cup 105 gram containing 5 to 10 billion Colony forming unit (CFU)/mg of Bifidobacterium animalis DN-173 010, Bifidobacterium lactis DN 173 010, Bifidobacterium lactis CNCM 1-2494, Lactobacillus bulgaricus, Streptococcus thermophiles, Lactococcus lactis and yeast tablets 400 mg one tablet per day for each patient each tablet containing 6 billion CFU/mg of probiotics Saccharomyces cerevisiae and Saccharomyces boulardii, along 3 months from the start of the study
OTHER	Standard medical treatment	standard medical treatment

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-09-01
• Completion: 2025-03-01
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: Egypt