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Development of surrogate end-point biomarkers for chronic fatigue and myalgic encephalmyelitis/chronic fatigue syndrome ( ME/CFS)

Development of surrogate end-point biomarkers for chronic fatigue and myalgic encephalmyelitis/chronic fatigue syndrome ( ME/CFS) - Development of surrogate biomarkers for ME/CFS

Status
Recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000029076
Enrollment
120
Registered
2017-09-12
Start date
2017-09-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myalgic encephalomyelitis/chronic fatigue sydnrome (ME/CFS) and healthy control

Interventions

None listed

Sponsors

Osaka City University
Lead Sponsor
RIKEN, Kyushu University, Yamaguchi University, Kansai University of Welfare Sciecnes, Nakatomi Fatigue Care Clinic, MI Clinic, Mie University, Astellas
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Meet diagnosis both CDC criteria (1994) and ME/CFS (2003)

Exclusion criteria

Exclusion criteria: 1) Pregnant women, those who are likely to become pregnant, those who are breastfeeding 2) Person who has metal, pacemaker in the body by surgery etc. 3) Claudophobia 4) Persons who have a history of feeling sick during blood sampling 5) Persons who are experiencing psychiatric diseases before suffering chronic fatigue syndrome 6) Person who has fatigue performance status less than 4 7) A person who falls under the exclusionary disorder in ME/CFS clinical diagnostic criteria(2016) of the Ministry of Health, Labor and Welfare, a person who has undergone diagnosis of cerebral spinal fluid reduction 8) Until three month's earlier PET examination, persons who are unable to stop taking drug which may affect microglial activation or Chinese medicine with anti-inflammatory effects 9) Until one month prior to the implementation of PET, persons who are unable to stop medicines that may affect microglia activation or high antipyretics analgesic drugs with COX-1 selection system 10) BMI less than 15, more than 30 11) Others who judged inappropriate by the attending physician 12) For healthy subjects, those with a history of anemia, those with chronic fatigue and malaise, those with a history of surgery within six months, those with a history of psychiatric diseases, workers with working over 100 hours per month or shift worker with night shift, person with sleep disorder, person who has been reexamined by health check within 6 months, more than 2 in fatigue performance status

Design outcomes

Primary

MeasureTime frame
The level of brain positive inflammation dected by positron emission tomography (PET), [F18]DPA-714

Secondary

MeasureTime frame
Oxidative stress level, Anti-oxidant activity, Metabolome, Proteome, Cytokines, Extracellular vesicles, Clinical test (CRP, cholesterol, etc.), CD antibody, Autonomic nervous system, Questionnaires for fatigue, depression and various symptoms, Arithmetic task, Sleep-wake cycle, Performance status for fatigue

Countries

Japan

Contacts

Public ContactHirohiko Kuratsune

Osaka City University Graduate School of Medicine

kura@med.osaka-cu.ac.jp06-6646-3033

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026