Driving research of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME / CFS),
Post Treatment Lyme Disease Syndrome (PTLDS), Fibromyalgia and Post COVID .

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Developing condensed precision research protocol for ME/CFS

PROTOCOL AIM
Establish a condensed personalized research protocol that can be used to characterize ME/CFS in individual patients as it pertains to all their unique biological aspects of their self, interacting with a complex chronic disease.
LEAD INVESTIGATORS
  • Christopher Armstrong, PhD
  • Paul Gooley, PhD
  • Neil McGregor, PhD
  • David Ascher, PhD
PROTOCOL VALUE

This protocol would be useful for tracking the development of ME/CFS, provide an understanding of the biology of the disease process in the individual, stratify ME/CFS individuals into biologically-defined subsets, test the efficacy of treatments, and monitor outcomes in clinical treatment trials. 

PROTOCOL DESCRIPTION

A condensed personalized research protocol would be the minimum number of samples from specific conditions that can accurately develop a biological signature unique to an individual with ME/CFS that can be used predict the improvement or worsening of their symptoms.

PROTOCOL DEVELOPMENT

Initially, the biology of 100 people with ME/CFS will be characterized by continuously monitoring their health data and sporadically sampling and analyzing their blood and urine over the course of a year.

Metabolite and Symptom Data will be analyzed to identify signatures of disease severity in individuals that predict increased and decreased disease severity.

Pattern-recognition software will be developed specifically to recognize these signatures and compare them across patients to identify patterns that can then reduce the complexity and length of the personalized research method.

NMR Metabolomics
NMR (Nuclear Magnetic Resonance) is an instrument/tool used to perform metabolic studies, metabolic profiling, and metabolomics in biofluids and tissues for more than 40 years using magnetic fields. There is a very close connection between metabolic measurements and NMR. This connection has flourished because of NMR’s many unique strengths for characterizing complex mixtures’ chemical composition.
Proteomics
The large-scale study of proteins, which are large, complex molecules that are required for structure, function, and regulation of the human body's tissues and organs.
Microvesicles and viral sequencing
Microvesicles are a type of extracellular vesicle that is released from the cell membrane. Vesicles are small, fluid-filled sacs or vacuoles within the body. Sequencing is a technique used to determine the exact sequence of bases (A, C, G, and T) in a DNA (or viral) molecule.
Autoantibodies
Antibodies that react with self-molecules and that occur in healthy individuals and are referred to as natural antibodies or autoantibodies.
Extracellular DNA for viral reactivation and Mitochondrial DNA
exDNA (extracellular DNA), exDNA is often secreted actively and is used to perform several tasks, thereby offering an attractive target or tool for biotechnological, medical, environmental, and general microbiological applications. Viruses are intracellular parasites that rely to a significant extent on the host cell for replication. Viral reactivation occurs when an active replication of the viral genome results in a lytic (degradation of the cell) infection characterized by the release of new progeny (descendant) virus particles.
Immune cell profiling
The immune system has many important regulatory roles in disease development and progression. Given the emergence of effective immune therapies, reliable predictors of response are needed. Immune cell profiling determines response by evaluating immune cell populations from treated and untreated samples. For our purposes, we will evaluate the white blood cell response to the viral infection using a process called “Cytof.”
Leukocyte Genomics
A leukocyte is a colorless cell circulating in the blood and body fluids and is involved in counteracting foreign substances and disease. A genome is all genetic material of an organism. Genomics is a biology field focusing on the structure, function, evolution, mapping, and editing of genomes. Therefore, leukocyte genomics is the study of all genetic material of leukocytes.
Metabolomics
Metabolomics is a way to study metabolism – that is, through measuring amounts of the metabolites (small molecules) produced by our bodies as we convert food into energy and other molecules that our cells need to survive. Metabolomics technology is ‘large-scale,’ meaning that several thousand metabolites can be measured from a single sample of e.g., blood or urine.
Micro RNA
Cells use Micro RNA to control whether a particular gene is making too much, too little or the normal amount of its protein at a particular time.