Compositions and methods for treating multiple sclerosis and related disorders

The present disclosure is in the field of pharmaceutical compositions acceptable for the treatment of diseases in mammals. The disclosure provides novel compositions comprising non-pathogenic mosquito germs for treating multiple sclerosis and related ailments. The disclosure also provides methods for treating a subject with all the compositions disclosed herein.

 

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BACKGROUND

 

 
Mammals harbor diverse microbial species within their gastrointestinal (GI) tracts. Interactions between these microbes and between microbes and the server, e.g. the host immune system, shape a microbiota. A healthy microbiota provides the host withmultiple advantages, including colonization resistance to a broad array of pathogens, essential nutrient biosynthesis and absorption, and immune stimulation which maintains a healthy gut epithelium and an appropriately controlled systemic immunity. Anunbalanced microbiota (also known as’dysbiosis’ or disrupted symbiosis) may lose its function and results in increased susceptibility to pathogens, modified metabolic profiles, or induction of proinflammatory signals that can lead to local or systemicinflammation or autoimmunity. Additionally, this type of disrupted microbiota might be infected with incoming pathogen or pathogens, which can cause pain, diarrhea, gas, and constipation along with other symptoms. Therefore, the intestinal microbiota plays a significantrole in the pathogenesis of several ailments such as pathogenic diseases of the gut.
 

 
Implantation or administration of human colonic microbiota into the gut of a sick patient is called Fecal Microbiota Transplantation (FMT), also commonly known as fecal bacteriotherapy. FMT is believed to repopulate the gut with a diversearray of microbes that control key pathogens by creating an ecological environment inimical to their proliferation and survival. It represents a therapeutic protocol that permits a speedy reconstitution of a typical compositional and functional gutmicrobial community.
 

 
FMT has been used to treat Clostridium difficile disease (CDI). FMT has also been indicated in treating other gut infective agents such as E. coli and Vancomycin resistant Enterococci (VRE). It entails infusions through a colonoscope, anenema or through a nasojejunal tube of individual microbiota either in the form of homogenised stool, or cultured stool components such as Clostridia, to implant in the colon and thus displace or eliminate pathogenic bacteria, e.g., C. difficile.
 

 
Without being bound to any theory, multiple sclerosis (MS) is considered by some as a disabling autoimmune disorder of the central nervous system. In multiple sclerosis the immune system attacks the protective myelin sheath of nerve fibers.Damage to the myelin sheath slows down or ceases nerve signaling and causes miscommunication between the brain and spinal cord and other parts of the body. The illness can progress to irreversible damage of the nerves. Multiple sclerosis is made up of fourdisease types, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), and secondary progressive multiple sclerosis (SPMS). Symptoms of multiple sclerosis vary dependingon the sum of nerve damage, location of harm and seriousness of this illness. Attacks can last for weeks, days, or months, followed by periods of remission. People who suffer from acute multiple sclerosis may eliminate the ability to walk. Other symptomscan include loss of balance, muscle fatigue, numbness, motor problems, tremors and limb weakness. Additional symptoms may affect the bowel or bladder. These include constipation and stool leakage, difficulty urinating, frequent urination, and urineleakage. A subject with multiple sclerosis may also have problems with double vision, eye discomfort, rapid eye movements and vision loss. Multiple sclerosis may additionally cause memory loss, difficulty solving problems, depression, hearing loss, slurred speechand difficulty with swallowing and chewing.
 

 
Current treatments for multiple sclerosis involve medication that could decrease or reduce symptoms and slow down the disease. Multiple sclerosis affects women more than men and is most commonly diagnosed between ages 20 to 40. Thehospitalization levels of multiple sclerosis patients decreased by 75 percent in 2011, in comparison with 1984, however, hospitalization rates of multiple sclerosis patients stay higher than hospitalization rates of the overall population. View, Marrie et al.,Neurology 2014; 83: 929-937. Thus, there’s a need for more effective therapies for multiple sclerosis which are simpler to administer.
 

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