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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of patients with improving in fatigue
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinically definite MS patients with a diagnosis of relapsing remitting multiple sclerosis according to revised McDonald criteria
- •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.
Arms & Interventions
Probiotic Group
probiotic dietary supplements
Intervention: Probiotic dietary supplement (Dietary Supplement)
Controlled group
standard treatment only
Intervention: Standard medical treatment (Other)
Outcomes
Primary Outcomes
Number of patients with improving in fatigue
Time Frame: 3 months
changes in fatigue status using modified fatigue impact scale which range from 0 to 84 where high scores worse outcome
Secondary Outcomes
- Inflammatory biomarkers(3 months)
Investigators
Foraysa Mohammed Talaat
Faculty of medicine, Cairo university
Cairo University