BHC drives innovative and emerging research pathways to define core signs, symptoms, and decrements in specific functioning. On this page, BHC explains biomarkers, elements of clinical research, and engagements in research projects.
Active & Recruiting - Participate in Research!
Contacting us does not mean that you are obligated or eligible to participate.
RESTORE ME: A RandomizEd Double Blind Placebo Control Trial to Determine the EffectS of OxaloaceTate On ImpRoving FatiguE in ME/CFS
New Clinical Research
The Bateman Horne Center is working with Terra Biological to test oxaloacetate, a nutritional supplement, in ME/CFS. Oxaloacetate is an energy metabolite that holds a key place in the TCA cycle – the cycle that is essential for the generation of energy. Half of the participants will receive capsules containing oxaloacetate and half will receive capsules with rice flour which will serve as the placebo.
The trial will last for 90 days. During this time there will be four (4) in-person visits to the Bateman Horne Center for a physical exam, assessments, blood collection, and fitted with a device to measure daily steps and upright position. Participants will be emailed short surveys to complete on a weekly basis throughout the trial. At the end of the study, participants will be provided with a 90-day supply of oxaloacetate if interested. Eligible participants will be compensated $50 for each in-person visit.
If you are interested, click on this link to provide us with your contact information.
Email: [email protected] or call (801) 532-8311
Active, No Longer Recruiting Research Participants
An Open-Label Pilot Study with the Combination of Valacyclovir and Celecoxib for the Treatment of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults
The Bateman Horne Center is conducting a pilot study to test whether a combination of celecoxib and valacyclovir reduces fatigue and other symptoms in women with Long COVID between the age of 18-65 years. The combination of celecoxib and valacyclovir may inhibit herpes virus activation and replication.
Endothelial Function and Upright Activity in ME/CFS and Long COVID
In February of this year, we began enrolling for a study to evaluate endothelial function in people with ME/CFS and Long COVID. “Endothelial” refers to the cells that line the inside of blood vessels. Endothelial cells are actively involved in contracting/relaxing the blood vessels, blood clotting, and immune function. Our aim is to assess endothelial function using the Endo PAT 2000 device, which measures Peripheral Arterial Tone (PAT) signal changes using non-invasive monitoring at the fingertip. We measure PAT at baseline, then again after reducing blood flow, and again after restoring normal blood flow. This process is called a reactive hyperemia challenge.
BHC Clinical Core for JAX: A 4-year NIH-funded Study to Identify Biomarkers
This study aims to identify the fundamental mechanisms by which a tri- component network of systems—the microbiome, metabolism and the immune system—interact to cause or exacerbate disease. BHC serves as the Clinical Core and is responsible for recruiting, clinically evaluating and collecting biological samples from ME/CFS and healthy volunteer research participants.
Research for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Disease: Understanding the Patient Experience of Fatigue
The pharmaceutical industry has been reluctant to invest in developing therapies for ME/CFS, in part because there are no measures of treatment outcome that they can rely on to provide evidence to the FDA. Fatigue is included in all commonly used case definitions for ME/CFS. A validated patient-reported outcome measure (PROM) for ME/CFS fatigue would provide the data required to document the treatment benefit of therapies for this disease. The objective of this study is to demonstrate that the PROMIS Fatigue measure is a valid and reliable outcome for use in clinical trials of therapy for ME/CFS.
Completed Studies
- FORTRESS Study: Trial of IMC-1 for the Treatment of Fibromyalgia
- Exagen-Better Study (20-FMS1-Better): Fibromyalgia Study
- A Study to Evaluate the Efficacy and Safety of TXN-102 SL in Patients with Fibromyalgia (RELIEF)
- Defining Posture Contributors to Post-Exertional Malaise
- Multisite Clinical Assessment of CFS: A CDC-funded study to understand ME/CFS
- InTiME: Pilot Phase 1/2 Clinical Trial To Investigate CT38 In the Treatment of ME/CFS
- Restore: A clinical trial of droxidopa for neurogenic orthostatic hypotension
- Juvenile Fibromyalgia Study (Ages 13-17): Duloxetine versus placebo
- Fibromyalgia Study (Ages 18-65): DS-5565 compared to pregabalin and placebo
- Fibromyalgia Study Low-dose cyclobenzaprine tablets (TNX-102 Phase III)
- Fibromyalgia: Neuropoint Device delivering RINCE treatment
- Chronic Fatigue Syndrome: Nutraceuticals & Low-dose methylphenidate
- Fibromyalgia: IMC-1 combination versus placebo
- Juvenile Fibromyalgia: Lyrica/pregabalin versus placebo
- Chronic Fatigue Syndrome: Poly I: Poly C12U IV drug (Ampligen) open label study
- Fibromyalgia: Low-dose sublingual cyclobenzaprine tablets (Phase II)
Research Publications
The following publications are a result of BHC led and/or partnered research findings
Post-exertional malaise among people with long COVID compared to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)
Importance: All but one Long COVID respondent reported having PEM. There were many significant differences in the types of PEM triggers, symptoms experienced during PEM, and ways to recover and prevent PEM between Long COVID and ME/CFS. Similarities between Long COVID and ME/CFS included low and medium physical and cognitive exertion to trigger PEM, symptoms of fatigue, pain, immune reaction, neurologic, orthostatic intolerance, and gastrointestinal symptoms during PEM, rest to recover from PEM, and pacing to prevent PEM.
View the full publication in the journal of WORK.
Deficient butyrate-producing capacity in the gut microbiome is associated with bacterial network disturbances and fatigue symptoms in ME/CFS
Importance: In this study, we employed shotgun metagenomics and metabolomics to assess dysbiosis in the largest prospective case-control study to date, consisting of 106 ME/CFS subjects and 91 matched healthy controls. Our findings provide insights into disturbances in the microbiome and their relationship with fatigue symptoms in ME/CFS.
View the full publication in the journal of Cell Host & Microbe.
Multi-‘omics of gut microbiome-host interactions in short- and long-term myalgic encephalomyelitis/chronic fatigue syndrome patients
Importance: The etiology of chronic fatigue syndrome (CFS) is largely unknown. In this issue of Cell Host and Microbe, Guo et al. and Xiong et al. report CFS-associated gut microbiome and metabolomic datasets-implicating dysregulation of immune-modulating molecules. This may provide a framework for new therapeutic paradigms and disease origins.
View the full publication in the journal of Cell Host & Microbe.
Improvement of Long COVID symptoms over one year
View the full publication in the journal of Frontiers in Medicine.
Orthostatic Challenge Causes Distinctive Symptomatic, Hemodynamic and Cognitive Responses in Long COVID and ME/CFS
Background: Some patients with acute COVID-19 are left with persistent, debilitating fatigue, cognitive impairment (“brain fog”), orthostatic intolerance (OI) and other symptoms (“Long COVID”). Many of the symptoms are like those of other post-infectious fatigue syndromes and may meet criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Common diagnostic laboratory tests are often unrevealing.
View the full publication in the journal of Frontiers in Medicine: Family and Primary Care
Dissecting the Nature of Post-Exertional Malaise
Background: Post-exertional malaise (PEM) is a defining characteristic of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) but there is insufficient research dissecting the nature of PEM from the patients’ perspective.
View the full publication in the journal of Fatigue : Biomedicine, Health & Behavior.
Accurate and objective determination for ME/CFS disease severity with a wearable sensor
Background: Approximately 2.5 million people in the U.S. suffer from myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). This disease negatively impacts patients’ ability to function, often resulting in difficulty maintaining employment, sustaining financial independence, engaging socially with others, and in particularly severe cases, consistently and adequately performing activities of daily living. The focus of this research was to develop a sensor-based method to measure upright activity defined as time with feet on the floor and referred to as UpTime, as an indicator of ME/CFS disease severity.
View the full publication in the Journal of Translational Medicine.
Hemodynamics during the 10-minute NASA Lean Test: Evidence of circulatory decompensation in a subset of ME/CFS patients
Background: Lightheadedness, fatigue, weakness, heart palpitations, cognitive dysfunction, muscle pain, and exercise intolerance are some of the symptoms of orthostatic intolerance (OI). There is substantial comorbidity of OI in ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome). The 10-minute NASA Lean Test (NLT) is a simple, point-of-care method that can aid ME/CFS diagnosis and guide management and treatment of OI. The objective of this study was to understand the hemodynamic changes that occur in ME/CFS patients during the 10-minute NLT.
View the full publication in the Journal of Translational Medicine.
Clinically accessible tools for documenting the impact of orthostatic intolerance on symptoms and function in ME/CFS
Background: Clinical observations have indicated that hours of upright activity (HUA) reported by Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients correlated with orthostatic symptoms and impaired physical function. This study examined the relationship between HUA and orthostatic intolerance (OI).
View the full publication in Work.
