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Clinical Trials/NCT06290453
NCT06290453Not yet recruitingNot Applicable

The Regulatory Role of miRNA 27 and Follistatin Like Protein-1 Gene in the Pathophysiology of Multiple Sclerosis Patients.

Assiut University0 sites60 target enrollmentStarted: March 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Primary Endpoint
• To measure the levels of miR-27 expression and its target gene (FSTL1) in progressive MS and relapsing-remitting multiple sclerosis (RRMS) patients.

Study Overview

Brief Summary

Multiple sclerosis (MS) is a neurodegenerative disease characterized by demyelination of the central nervous system. Young women between the ages of 20 and 40 are primarily targeted by this disabling disorder. Till now there are no sufficient mechanisms to explain the pathophysiology of multiple sclerosis.

Detailed Description

Neuroinflammation has been implicated in the initiation and progression of several central nervous system (CNS) disorders, including multiple sclerosis. Microglia and astrocytes are essential in neural development, maintenance of synaptic connections, and homeostasis in a healthy brain.

Recent researchers have discovered that microRNAs (miRNAs) contribute to the pathophysiology of MS, primarily influencing glial cells and the immune cells in the periphery. In recent years, miRNAs have become more prevalent as inflammation and demyelination process regulators in MS.

miRNAs are naturally occurring, non-coding RNA molecules (21-25 nucleotides). miRNAs play a part in the post-transcriptional regulation of gene expression and silencing of RNA. miRNAs have been discovered to control some physiological processes, as apoptosis, proliferation, differentiation, and development.

Measurement of circulating miRNAs in MS patients' peripheral blood is one of the promising approaches as it can be a non-invasive tool to explain its pathogenesis. miRNAs are remarkably stable in bodily fluids and are relatively simple to collect and quantify. Moreover, a novel approach to therapy may be based on methods that regulate the activity of miRNAs.

Several miRNAs particularly miR-27 have been reportedly involved in regulating myelination in the central nervous system. However, the role of micro RNAs in generation or progression of MS remains elusive.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
20 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients diagnosed with MS based on the revised McDonald criteria.
  • Female patients will only be included.
  • 20- 45 years old.
  • Drug naïve.

Exclusion Criteria

  • Patients with other neurodegenerative and autoimmune disorders.
  • Pregnant females.
  • Co-existing chronic hypertension, diabetes, and epilepsy
  • chronic renal or hepatic diseases

Outcomes

Primary Outcomes

• To measure the levels of miR-27 expression and its target gene (FSTL1) in progressive MS and relapsing-remitting multiple sclerosis (RRMS) patients.

Time Frame: 1 month

RNA extraction Reverse Transcription polymerase chain reaction (RT-PCR) analysis:

Secondary Outcomes

  • To correlate the levels of expression of miR-27 expression and its target gene (FSTL1) relative to the severity of symptoms of MD patients.(1 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rasha Mohammed Ali

Lecturer of medical physiology

Assiut University

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