MedPath

To study the effect of microbial flora of the gut on brain (gut-brain axis) in Multiple Sclerosis patients

Phase 2
Conditions
Health Condition 1: G35- Multiple sclerosis
Registration Number
CTRI/2020/08/027453
Lead Sponsor
niversity Grants Commission
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. RRMS and Aggressive MS patients (both naïve and on DMTs) as per the 2017 McDonald diagnostic criteria.

2. Last dose of steroids more than one month of duration.

3. EDSS score equal to or less than 5.5.

4. Naive RRMS Patients should not have been exposed to DMTs or taken the last dose 6 months back.

5. Willing to participate and sign the Informed consent.

Exclusion Criteria

1. Patients with progressive forms of MS (SPMS, PPMS) and Neuromyelitis optica spectrum disorders (NMO SD).

2. Pregnancy and lactating females.

3. Patients with diabetes, chronic illnesses such as Tuberculosis (TB), human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBs Ag), Hepatitis C, cancer etc. and immunological disorders such as Lupus, Rheumatoid arthritis, Inflammatory bowel disease (IBD) etc.

4. Patients with chronic neurodegenerative disorders e.g. Parkinson’s disease (PD), amyotrophic lateral sclerosis (ALS), Huntington’s disease etc.

5. Patients on any immunosuppression therapy, taking probiotics, antibiotics, steroids, Nonsteroidal anti-inflammatory drugs (NSAIDs) within last one month.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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