Adamczyk-Sowa M, Medrek A, Madej P, Michlicka W, Dobrakowski P Does the Gut Microbiota Influence Immunity and Inflammation in Multiple Sclerosis Pathophysiology? J Immunol Res. 2017;2017:7904821. doi: 10.1155/2017/7904821. Epub 2017 Feb 20. Review.
Camara-Lemarroy CR, Metz LM, Yong VW Focus on the gut-brain axis: Multiple sclerosis, the intestinal barrier and the microbiome. World J Gastroenterol. 2018 Oct 7;24(37):4217-4223. doi: 10.3748/wjg.v24.i37.4217.
Chu F, Shi M, Lang Y, Shen D, Jin T, Zhu J, Cui L Gut Microbiota in Multiple Sclerosis and Experimental Autoimmune Encephalomyelitis: Current Applications and Future Perspectives. Mediators Inflamm. 2018 Apr 2;2018:8168717. doi: 10.1155/2018/8168717. eCollection 2018. Review.
Hooper LV, Littman DR, Macpherson AJ Interactions between the microbiota and the immune system. Science. 2012 Jun 8;336(6086):1268-73. doi: 10.1126/science.1223490. Epub 2012 Jun 6. Review.
Kaskow BJ, Baecher-Allan C Effector T Cells in Multiple Sclerosis. Cold Spring Harb Perspect Med. 2018 Apr 2;8(4). pii: a029025. doi: 10.1101/cshperspect.a029025. Review.
Kirby TO, Ochoa-Repáraz J The Gut Microbiome in Multiple Sclerosis: A Potential Therapeutic Avenue. Med Sci (Basel). 2018 Aug 24;6(3). pii: E69. doi: 10.3390/medsci6030069. Review.
Makkawi S, Camara-Lemarroy C, Metz L Fecal microbiota transplantation associated with 10 years of stability in a patient with SPMS. Neurol Neuroimmunol Neuroinflamm. 2018 Apr 3;5(4):e459. doi: 10.1212/NXI.0000000000000459. eCollection 2018 Jul.
Ochoa-Repáraz J, Magori K, Kasper LH The chicken or the egg dilemma: intestinal dysbiosis in multiple sclerosis. Ann Transl Med. 2017 Mar;5(6):145. doi: 10.21037/atm.2017.01.18.
Quintana FJ, Prinz M A gut feeling about multiple sclerosis. Proc Natl Acad Sci U S A. 2017 Oct 3;114(40):10528-10529. doi: 10.1073/pnas.1714260114. Epub 2017 Sep 25.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
