Effect of Probiotics on Relapsing-Remitting Multiple Sclerosis (PRO-RRMS)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal