Multiple Sclerosis (MS) Relapsing Remitting
Conditions
Keywords
fatigue, depression, disability
Brief 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.
Interventions
DIETARY_SUPPLEMENTProbiotic 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
OTHERStandard medical treatment
standard medical treatment
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Clinically definite MS patients with a diagnosis of relapsing remitting multiple sclerosis according to revised McDonald criteria 2017. * EDSS score of ≤ 4
Exclusion criteria
* Progressive MS either; primary progressive MS or secondary progressive MS * Patients who had relapses and glucocorticoid therapy within the past 30 days. * Pregnancy and women who were lactating within the prior six month * Patients taking antibiotics * History of gastroenteritis and bowel surgery over the past month, inflammatory bowel disease * Presence of diabetes (type I \& type II) or diseases causing significant nutritional status impairment (malignancy, chronic infections) * Patients who have changed their disease modifying drugs in the past 6 months prior to study * Impaired cognition that limited ability to complete the questionnaires. Addiction to drugs or alcohol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with improving in fatigue | 3 months | changes in fatigue status using modified fatigue impact scale which range from 0 to 84 where high scores worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory biomarkers | 3 months | alterations in inflammatory biomarkers such as cytokines and other immune mediators |
Countries
Egypt
Outcome results
None listed