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Defining Autoimmune Aspects in Severe ME/CFS (UK study, participant recruitment by invitation only).

Jo Best

Jo Best

Senior Member
Messages
1,032
Latest study in the translational biomedical research programme initiated by Invest in ME Research and focusing on the role of infection and the immune system in ME/CFS including autoimmunity.

Enrollment by invitation only (Severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients will be identified by Epsom and St Helier CFS Service and the Clinical Research Network Eastern.)

Household controls will be recruited through patients participating in the study.

Brief Title:
Autoimmunity in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Official Title:
Defining Autoimmune Aspects of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Brief Description:
This study investigates whether there is an immune response directed against gut microbes or food and parts of the body in severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients.

Main ID: NCT03254823

Principal Investigator: Simon Carding

Primary Sponsor: University of East Anglia

Secondary Sponsors: Quadram Institute and Invest in ME Research

Estimated Completion Date: 30 September 2020

Current Primary Outcome Measures:
  • Measurement of antibody levels [ Time Frame: 3 years ]

  • Measurement of serum antibodies that are reactive with intestinal microbes or foods. Antibody levels will reflect the presence of an immune response directed against gut microbes in severe ME/CFS patients.

  • Measurement of cellular immune responses [ Time Frame: 3 years ]

    Measurement of memory T and memory B cells (from peripheral blood mononuclear cells in the blood) specific to gut microbes (from stool sample). The presence of memory T and B cells will indicate a systemic (whole body) immune response directed against gut microbes in severe ME/CFS patients.

  • Expression of microbial and viral DNA/RNA [ Time Frame: 3 years ]

    To identify the bacterial, fungal and virus populations in stool samples.
Current Secondary Outcome Measures:
  • Measurement of autoimmunity [ Time Frame: 3 years ]

  • Measurement of serum antibodies and immune cells that are reactive with human cells, such as cells of the central nervous system. The presence of an immune response against human cells and human cell proteins is indicative of the presence of autoimmunity.
Links to study details:

WHO International Clinical Trials Registry Platform:
http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03254823

NIH Clinical Trials.gov:
https://clinicaltrials.gov/ct2/show/record/NCT03254823

NHS choices:
http://www.nhs.uk/Conditions/Chronic-fatigue-syndrome/Pages/clinical-trial-details.aspx?TrialId=NCT03254823&Condition=Chronic fatigue syndrome&pn=1&Rec=0&CT=0

Other links:

Quadram Institute:
https://quadram.ac.uk/targets/me-cfs/

Invest in ME Research:
http://www.investinme.org/index.shtml

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Murph

Murph

:)
Messages
1,799
Inclusion Criteria:

  • severe ME/CFS patients: men or women aged 18 to 70 years with a clinical diagnosis of severe ME/CFS patients
  • household controls: men or women aged 18 to 70 years, no current or on-going medical conditions. Has to be either related/non-related, living in the same household or in close proximity to, or providing care to the severe ME/CFS patient they are paired with.
Exclusion Criteria:

  • severe ME/CFS patients: the presence of significant anxiety or depression. Have received probiotics or antibiotics up to six weeks before joining the study.
  • Household controls: The presence of long term medical conditions, in particular, affecting the stomach or bowel. Previously diagnosed with autoimmune diseases, for example, systemic lupus erythematous or rheumatoid arthritis. Suffer from significant anxiety or depression. In recipient of immunomodulatory drugs, statins, beta blocker or steroids. Have received probiotics or antibiotics up to six weeks before joining the study.
 
trishrhymes

trishrhymes

Senior Member
Messages
2,158
Sounds fascinating. Do they say how many participants they hope to study? I imagine with all the exclusion criteria it could be quite hard to get enough patients with suitable controls in their household. So frustrating that it will take until 2020 to complete.
 
Jo Best

Jo Best

Senior Member
Messages
1,032
trishrhymes said:
Sounds fascinating. Do they say how many participants they hope to study? I imagine with all the exclusion criteria it could be quite hard to get enough patients with suitable controls in their household. So frustrating that it will take until 2020 to complete.
Click to expand...
It says target enrollment is 20 Trish, and I assume that means 20 patients and 20 controls.

Yes the time it takes is frustrating for everyone involved but has to start some time and be carefully done.

They started taking patient samples in 2014 for the foundation study on leaky gut, so next phases have built from there and is, of course, also linked with the planned rituximab trial and UCL-based B-cell research. ETA latest on that: http://investinme.org/ce-news-1708-01.shtml
 
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Jo Best

Jo Best

Senior Member
Messages
1,032
Three review articles have been published by the team to date:

1/ Navaneetharaja N., Griffiths V., Wileman T., Carding S.R. (2016).
A Role for the Intestinal Microbiota and Virome in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS),
J. Clin. Med. 5, 55; doi:10.3390/jcm5060055
http://www.mdpi.com/2077-0383/5/6/55

2/ Cambridge, G., Mensah, F. K. F., Bansal, A. S., & Ford, B. (2017).
Chronic fatigue syndrome and the immunesystem: Where are we now?. Neurophysiologie Clinique/Clinical Neurophysiology. doi:10.1016/j.neucli.2017.02.002
http://discovery.ucl.ac.uk/1551588/

3/ S. R. Carding, N. Davis, L. Hoyles (2017)
Review article: the human intestinal virome in health and disease
Ap&T. DOI: 10.1111/apt.14280
http://onlinelibrary.wiley.com/doi/10.1111/apt.14280/full

(as well as the paper on the initial B-cell study):
Mensah, F., Bansal, A., Berkovitz, S., Sharma, A., Reddy, V., Leandro, M. J., & Cambridge, G. (2016). Extended B cell phenotype in patients with myalgic encephalomyelitis/chronic fatigue syndrome: a cross-sectional study. CLINICAL AND EXPERIMENTAL IMMUNOLOGY, 184 (2), 237-247. doi:10.1111/cei.12749
http://onlinelibrary.wiley.com/doi/10.1111/cei.12749/abstract
 
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trishrhymes

trishrhymes

Senior Member
Messages
2,158
Jo Best said:
It says target enrollment is 20 Trish, and I assume that means 20 patients and 20 controls.

Yes the time it takes is frustrating for everyone involved but has to start some time and be carefully done.

They started taking patient samples in 2014 for the foundation study on leaky gut, so next phases have built from there and is, of course, also linked with the planned rituximab trial and UCL-based B-cell research.
Click to expand...

Thanks Jo, the frustration over the time it takes wasn't meant as a criticism, just frustration that these things always take so long. I'm not getting any younger and I want answers. I'm glad they are doing it and feel confident they will do it well. It is exciting to see good research happening in the UK. Many thanks to Invest in ME.
 
Jo Best

Jo Best

Senior Member
Messages
1,032
trishrhymes said:
Thanks Jo, the frustration over the time it takes wasn't meant as a criticism, just frustration that these things always take so long. I'm not getting any younger and I want answers. I'm glad they are doing it and feel confident they will do it well. It is exciting to see good research happening in the UK. Many thanks to Invest in ME.
Click to expand...
No worries Trish, I know what you meant and genuinely mean you speak for everyone involved.
Invest in ME Research said on Facebook just the other day,
"Of course, we understand – it is all too slow.
It is for us too.
But we have no alternative".

From the researchers' perspective, I think in this interview in January, Simon Carding expresses how sincerely keen they are to help us all and get the treatment trials going asap.

 
Jo Best

Jo Best

Senior Member
Messages
1,032
Two of the PhD students involved in the gut microbiota research, Katharine Seton and Fiona Newberry, presented at a German Institute of Human Nutrition event in Berlin on Monday 11th September 2017.

Katharine's presentation was entitled

"Immune reactivity to enterobacteria in ME/CFS"
.
Fiona's presentation was entitled

"Investigating the intestinal virile in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome"
.
Katharine and Fiona presented .[/QUOTE]

More at: http://www.investinme.org/ce-news-1709-03.shtml
 
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