Clinical Trials

On this page you will find ongoing ME/CFS clinical trials looking for participants. For more ongoing clinical trials as well as completed clinical trials go to Clinicaltrials.gov

You can read about the latest resources for investigating the causes and mechanisms of ME/CFS here: New resources for large-scale ME/CFS research

Be sure to check the Institute for Neuro-Immune Medicine for their ongoing trials.






 

Open Medicine Foundation: Study ME

Our goal is to enhance the quality of life for individuals affected by ME/CFS, Long Covid, Fibromyalgia, and other post-infection illnesses by expediting research in these areas and increasing awareness by showing how many people are waiting for a cure. Signing up is easy and takes less than five minutes. All you need to do is provide your contact details and specify your areas of interest. Once you’ve done this, we’ll send you email notifications whenever there are research opportunities that align with your interests to potentially participate in surveys, laboratory studies, or treatment trials.


INIM: The Use Of Directed Probiotics In ME/CFS
In this study, we aim to use the probiotic, Floradapt Intensive GI (other name i3.1), to reduce gastrointestinal (GI) inflammation and normalize the GI, to determine whether resetting your microbiome will help your gut health and perhaps your body as well while simultaneously assessing the effectiveness and safety of this intervention based on the severity of illness.

Who can Participate?
INIM Researchers will evaluate the use of probiotics in 100 participants who:

Are between 45 to 70 years of age
Meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS
May or may not be diagnosed with irritable bowel syndrome (IBS)

For more information, please email KanekaStudy@nova.edu.



 Pain and Fatigue Study Center at Mt. Sinai is conducting several studies

Patients with ME/CFS and Balance Problems

Many patients with ME/CFS have problems maintaining balance. This new study tests the individual patient for that problem and then applies a treatment — activation of the part that modulates balance via a battery-operated stimulator. The purpose of the study is to determine if this experimental treatment improves balance. If you are interested in participating in this study, please contact us either via email to info@painandfatigue.com or phone at 212-844-6665.

MRI Imaging to Compare Chronic Fatigue Syndrome Occurring With or Without Prior Covid-19 Infection
Many COVID-19 survivors remain ill with symptoms such as fatigue and brain fog. The symptoms are indicative of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). In this project, we will do magnetic resonance imaging of the brain to compare the images between long-COVID-ME/CFS and classic ME/CFS patients, as well as to individuals not affected by ME/CFS. Participants will be asked to undergo eligibility screening, complete a MRI scan, and answer questionnaires. Participants will be paid $100 upon completing the study. Knowledge learned from this study will deepen our understanding of ME/CFS/long-COVID disease mechanisms, aid in ME/CFS diagnosis, inform treatment decisions, and inspire new treatment targets. If you experience long-COVID or ME/CFS, or are a healthy individual, and are interested in participating in this study, please call 212-844-6665 or sign up at https://forms.gle/1uW36fMfjrFuNATX8

Use of Rocking Bed to Demonstrate Pathophysiologic Sleep Differences between Chronic Fatigue Syndrome with and without Co-existing Fibromyalgia
The pattern of sleep differs for patients with CFS alone versus those who also have FM. While some researchers believe the two illnesses are the same, we have done many studies indicating they are different – with different underlying causes and different probable avenues to treatment. To further test this idea, we will study sleep during afternoon naps done at the MSSM Sleep Lab. One nap will be done on a regular bed while the second will be done on a bed that moves back and forth like a cradle. Our idea is that some but not all CFS patients will feel better after the nap on the rocking bed compared to healthy controls. If you are a patient, interested in participating in this study or if you know of a healthy person who does not take any medications, please call 212-844-6665.

To examine why post activity fatigue, also known as post-exertional malaise (PEM) occurs in patients with myalgic encephalomyelitis/chronic fatigue syndrome [CFS] and at what level
Current thinking is two cardiac stress tests a day apart can be used to assess the common ME/CFS complaint of post-exertional malaise. Our government medical research agency, the NIH, has provided us funds to examine this link. One reason that exertion may trigger PEM might relate to reductions in blood volume which occur when a person has to rest. We are asking patients with ME/CFS as well as one healthy friend or relative to consider coming to Mount Sinai for testing. After we assure that you are either an ME/CFS patient or a healthy comparison person, we will determine your blood volume and then ask you to do two sequential cardiac stress tests. If your blood volume is reduced, you may get an infusion of saline designed to repair this deficit. Reimbursement for time and travel will be available. If you are interested in possibly participating in this study, please call us at 212-844-6665.


Serimmune Covid-19 Immunity Study

Our goal is to understand differences in personal immune response to infection by the COVID-19 virus, SARS-CoV-2. Each individual makes their own unique set of antibodies to SARS-CoV-2, and in this study we will investigate how these differences may be important for immunity, the duration of immunity, and for severity of symptoms.

Read Cort Johnson’s informative post about the study HERE.


Four New Clinical Trials in 2022 – Bateman Horne Center

We will begin enrolling for a clinical trial of oxaloacetate in mid-April.  Oxaloacetate is an energy metabolite that holds a key place in the TCA cycle –the cycle that is essential for the generation of energy. Virios Therapeutics announced a collaboration with us to conduct a pilot clinical trial that tests a combination of valacyclovir plus celecoxib to treat Long COVID symptoms.


Trans-NIH Myalgic Encephalomyelitis / Chronic Fatigue Syndrome Working Group is conducting a large study. Participants are needed.

The NIH intramural clinical study on ME/CFS to take place at the NIH Clinical Center will focus on post-infectious ME/CFS in order to closely examine the clinical and biological characteristics of the disorder and improve our understanding of its cause and progression. The eligibility criteria for this study includes three groups of adults that either: 1) have ME/CFS with post exertional malaise fulfilling multiple consensus criteria; 2) had Lyme disease, were treated, and don’t have fatigue symptoms; or 3) are healthy volunteers. These groups were selected so that comparisons can be made between the groups to look for differences and similarities that may exist, using the unique resources of the NIH Clinical Center. All individuals will be very carefully characterized for all of the symptoms of ME/CFS using multiple criteria. The narrow scientific focus of this study is only the first step of what NIH hopes will be a broader national approach to better understand the biological basis of ME/CFS and the development of effective therapies. Learn more about this study: http://mecfs.ctss.nih.gov.


Sleep Disturbances in ME/CFS

Sponsor: OMF
Study duration: 18 months
Conducted at The Harvard ME/CFS Collaboration at the Harvard Affiliated Hospitals

The study will examine EEG frequencies (electrical activity occurring in the brain) of sleep and wakefulness in ME/CFS patients. Concurrently, Dr. Jonas Bergquist will evaluate cerebrospinal fluid proteomics at the Uppsala Collaborative Research Center. Dr Bergquist hopes to identify orexin (a neuropeptide that regulates arousal, and wakefulness) and related proteomic inflammatory markers in patients who have developed ME/CFS.


Decode ME

Join the world’s largest genetic ME/CFS study! We aim to find genetic causes of why people become ill with myalgic encephalomyelitis (ME) / Chronic Fatigue Syndrome (CFS) with our groundbreaking research. Join us.

Decode ME opens for first participants January 31, 2022. Read more here.


Novel Dynamic Proteomics Approaches to Investigate the Systems Level Pathology of ME/CFS.

A pilot study from researchers at Nottingham University (UK) will dynamically examine proteins in people with ME/CFS and compare them to healthy controls. This impressive team of experts need 10 females with ME/CFS between 20 and 50 years old (and 10 healthy females of similar age) at this stage, but we hope that if the results prove interesting, then they will be able to apply for a much bigger grant and recruit more of both sexes in the future.”