An observational study in Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, sponsored by University of East Anglia. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by University of East Anglia · Observational
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Among 10 studies in Fatigue Syndrome, Chronic with a site in United Kingdom — 4 open to participants now, 5 under way, none of them phase 3. Fatigue Syndrome, Chronic · United Kingdom.
Among the 10 studies in Fatigue Syndrome, Chronic with a site in United Kingdom, this one is the only one that started in 2017, is one of 6 observational ones, and was the 4th registered.
264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.
Browse Fatigue Syndrome, Chronic studies →4 of the 10 studies in Fatigue Syndrome, Chronic with a site in United Kingdom are open now. Recruiting first, the newest first:
Oxford Brookes University · Sites in United Kingdom
Ages 18–80 · Healthy volunteers
King's College London · Sites in United Kingdom
Ages 18+
Quadram Institute Bioscience · Sites in United Kingdom
Ages 18+
King's College London · Sites in United Kingdom
Ages 18–99 · Healthy volunteers
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 44 Fatigue Syndrome, Chronic studies recruiting now, 18 (41%) set no upper age limit and 20 (45%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · healthy volunteers too.
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10 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2017.
This study's enrollment of 10 is below the median of 150 across 77 observational studies indexed under Fatigue Syndrome, Chronic.
Median enrollment 17 across the 4 interventional studies, 87 across the 6 observational. Of the 5 that completed or were terminated, 2 (40%) have results posted.
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None of the 10 has an industry lead sponsor. The 9 most frequent:
University of East Anglia is the lead sponsor of 79 studies on the registry; 4 are open to participants now.
University of East Anglia has 1 study filed under Fatigue Syndrome, Chronic — fewer than ten, so there is no comparison to draw.
1 of the studies in Fatigue Syndrome, Chronic with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07874217Oxford Brookes UniversityWhole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study | 2027-01-08 |
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Among the 10 studies in Fatigue Syndrome, Chronic with a site in United Kingdom, from their registry updates:
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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.
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. Information sheets will be posted by health professionals to eligible patients. Interested patients are asked to arrange a telephone call with the research team to receive more information about the study. Volunteers still interested after the 72 hour consideration period arrange a home visit to be taken through the consenting process.
Household controls will be recruited through patients participating in the study. Patients invited will be provided with information about household controls. The patient identifies and informs potential household controls of the study using information sheets provided by their health professional. Household controls willing to participate in the study will be taken through an eligibility questionnaire with GCP trained researchers.
Six stool and blood samples will be collected over the three year study period. Stool and blood samples need to be collected within 24 hours of each other, during home visits. 48 hour food diaries will be completed prior to each stool sample collection.
The study is based at the Quadram Institute and the University of East Anglia (UEA). The research is funded by the UEA and Invest in ME Research UK.
Severe ME/CFS patient attending Epsom and St Helier CFS Clinic will be identified by the Director of the clinic, Dr Bansal. CRN Eastern will notify general practitioners and occupational therapists of the study. They will then identify severe ME/CFS patients in the East of England.
Household controls will be recruited through severe ME/CFS patients participating in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients with a clinical diagnosis of ME/CFS and are house or bed bound.
Healthy human participants who are either related/non-related to, living in the same household or in close proximity to, or providing care to the severe ME/CFS patient they are paired with. They are used as an environmental control.
Measurement of antibody levels
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.
Time frame: 3 years
Measurement of cellular immune responses
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.
Time frame: 3 years
Expression of microbial and viral DNA/RNA
To identify the bacterial, fungal and virus populations in stool samples.
Time frame: 3 years
Measurement of autoimmunity
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.
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in Aug 2022, 60 months.
Of 39 non-industry observational studies under Fatigue Syndrome, Chronic, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 79. This study's 60 months is above that.
Counting every sponsor, half of 41 studies reached it within 44 months; a quarter within 25 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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University of East Anglia