Health Condition 1: G35- Multiple sclerosis
Conditions
Interventions
Intervention1: Probiotic supplementation: Participants will be randomised in a 1:1 ratio to receive either an oral probiotic capsule or a matching placebo capsule once daily for a duration of 6 months
Sponsors
JIPMER (Intramural Grant)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults 18-55 years with Relapsing-Remitting MS (RRMS) as per McDonald 2017 criteria 2. EDSS score: 1.0-5.5 3. Stable DMT for at least 3 months 4. At least one documented clinical relapse or MRI activity in the last 2 years
Exclusion criteria
Exclusion criteria: 1. Primary or Secondary Progressive MS 2. Recent probiotic or antibiotic use for 5 days in a week within the past 4 weeks 3. Active infection or gastrointestinal disease, recent GI surgery 4. Pregnancy or breastfeeding 5. Presence of uncontrolled medical conditions such as advanced cardiovascular disease, chronic kidney disease (stage 4 or higher), liver failure, uncontrolled diabetes mellitus, or malignancies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disability progression as measured by the Expanded Disability Status Scale (EDSS)Timepoint: at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Annualised relapse rateTimepoint: 12 months;Radiologic disease activity as measured by new or enlarging T2 lesions and CEL on MRITimepoint: 12 months;Fatigue using Fatigue Severity Scale (FSS)Timepoint: 6 months;Quality of life using the MS Quality of Life- 54 questionnaireTimepoint: 6 months;Adverse effectsTimepoint: 3 and 6 months;Serum IL-6, IL-10, hsCRP, serum NfLTimepoint: Baseline and 6 months | — |
Countries
India
Contacts
Public ContactSaranya B Gomathy
Jawaharlal Institute of Postgraduate Medical Education and Research
Outcome results
None listed