PRO-RRMS
We could not find results for this trial
I know where the results areWhat it found
We found no results in the registry or in papers.
This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Probiotic dietary supplement
Placebo or sham
- Standard medical treatment
What it measured
Main measures
Number of patients with improving in fatigue
3 months
Fatigue
Other measures (1)
Inflammatory biomarkers
3 months
Blood or spinal fluid markersImmune response
Who could take part
Relapsing MS · 20 to 60
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Jan 2024
Main results due
Sept 2024
Finished
Mar 2025
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