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

Microbiome Signature in Indian Multiple Sclerosis

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/08/027453
Enrollment
100
Registered
2020-08-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G35- Multiple sclerosis

Interventions

Intervention1: Not Applicable: Not Applicable Control Intervention1: Not Applicable: Not Applicable

Sponsors

University Grants Commission
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Microbiome CharacterisationTimepoint: 12 months

Secondary

MeasureTime frame
Microbiome characterisation of Aggressive Multiple SclerosisTimepoint: 12 months

Countries

India

Contacts

Public ContactGurkeerat Kaur

Postgraduate Institute of Medical Education and Research (PGIMER)

khurana.dheeraj@pgimer.edu.in7087009695

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026