Announcing OMF's First ME/CFS Clinical Trial!

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

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Home Visit Study

STUDY AIM

This study provides a unique opportunity to bring the lab directly into patient homes and provide immediate analysis of samples over an extended period of time. This longitudinal approach without the invasive and/or PEM-induced measures will be vitally important in other patient cohorts and will decrease the study impact on patients from using more invasive and impactful measures (use of 1 peripheral vein catheter for all blood samples, limits the impact on patients).

LEAD INVESTIGATORS
  • Jonas Bergquist, MD, PhD
UPDATES AND POTENTIAL
  • IRB approval completed.
  • Over 3000 samples collected, and each will be initially analyzed with MS metabolomics (and potentially with NMR if needed).

STUDY HYPOTHESIS AND DESCRIPTION

Combined with clinical data and survey data, this massive data set should provide a significant picture to understand post-viral diseases.

  • Energy metabolism markers during mild mental and physical exertion analyzed on-site inpatient homes with immediate analysis of samples.
  • Samples collected every 5-15 minutes over 6-7 hours, monitoring in real time baseline compared to longitudinal data.
  • Complement this with full metabolomics screening to compare and contrast the findings in metabolic/mitochondrial disturbances over time.
  • Targeting 25 PWME (ell/SIPS) + 25 Controls + 25 Contrast (elite athletes)

OBJECTIVES

  • Pattern biology that corresponds to patient symptoms over the course of a day in two international cohorts (Sweden, Australia)
  • Track the biological impact of meals, social tasks, mental tasks, and exercise tasks, on ME/CFS patients compared to controls
  • Cluster patients based on similar biology-symptom dynamics.

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.
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.
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.”