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Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME / CFS) Post Treatment Lyme Disease Syndrome (PTLDS), Fibromyalgia Leading Research. Delivering Hope.Open Medicine Foundation® Canada
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Personalized Treatment Trials: Monitoring and Improving the Connection of Treatments to Patients

Study Aim

The study will deeply characterize patients before, during and after treatments are trialed through their General Practitioner (GP). Producing large scale data in combination with treatment outcome will be used to produce a predictive algorithm to improve the connection of patients to appropriate treatment options sooner.

Investigators

  • Natalie Thomas, PhD
  • Katherine Huang, PhD
  • David Fineberg, MBBS, FRACGP, DCH
  • Neil McGregor, PhD
  • Michael Menden, PhD
  • Christopher Armstrong, PhD

Updates and Potential

  • We have ethics approval for the first part of the project, and recruitment has begun.
  • The ethics application for the main trial has been submitted, and we are awaiting approval.
  • We have engaged another PhD student and a post-doctoral researcher who will begin in September 2024.
STUDY HYPOTHESIS AND DESCRIPTION

We’re conducting a study to closely watch how different treatments affect ME/CFS and Long COVID patients, using a very tailored approach. We’ll collect samples from patients before, during, and after their treatment to see what biological changes happen and how these relate to whether they feel better or not. This method will help us figure out which treatments work, why they work, and who they work best for.

We plan to study 200 patients over three years. Each patient will be part of the study for about 3 to 4 months, during which they will try 2 to 3 different treatments. This includes three visits to the clinic and involves analyzing many samples they provide, like blood and urine. This large collection of data from all the patients will help us make better predictions about which treatments are most likely to help others in the future.

OBJECTIVES

The image depicts a healthcare setting where a young female healthcare worker, wearing a blue scrub top and a stethoscope around her neck, is holding the hands of an older patient.

  1. Pattern biology that corresponds to symptom/disease changes induced by treatment.
  2. Sample blood before and after exertion as a measure of improved exertion tolerance.
  3. Cluster patients based on biology-symptom dynamic and identify effective treatments.

Consent management

Consent Preferences

Data Subject Access Request (DSAR) Form 

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.
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.
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.