Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Conditions
Keywords
ME/CFS, myalgic encephalomyelitis, chronic fatigue syndrome
Brief summary
CHIIME is a study of people who have myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). People who do not have this condition will also be enrolled. Volunteers will be observed and sampled over time to identify the long-terms biological drivers and impact of their condition. The overall goal is to understand the biological and physiological mechanisms that are driving this condition.
Detailed description
CHIIME is an observational, prospective study of individuals who have myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The overall objective of the study is to investigate the clinical characteristics and biological signatures of ME/CFS over time by performing deep clinical phenotyping with high-quality biospecimen collection and curation of individuals with and without the condition. Enrolled volunteers will be seen at San Francisco General Hospital. Visits include a detailed interview, biospecimen collection, and various assessments. No personal identifiers are used for specimen bank samples.
Interventions
None listed
Sponsors
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Willing and able to provide written informed consent * At least 18 years of age * Either: (1) a reported diagnosis of ME/CFS or (2) no history of ME/CFS or other infection-associated chronic conditions (healthy control)
Exclusion criteria
* Self reported or documented chronic anemia with hemoglobin \<9 g/dL * Known HIV, hepatitis B, or hepatitis C infection * Diagnosis of an infection-associated chronic condition other than ME/CFS or Long COVID (e.g. chronic Lyme disease, post-Ebola syndrome, etc.) * Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent * Active drug or alcohol use or dependence that, in the opinion of the PI, would interfere with adherence to study requirements or to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Sex | Baseline Visit | The proportion of men and women participating in the baseline visit. |
| Participant Age | Baseline Visit | The median age of study participants at enrollment. |
| Participant race/ethnicity | Baseline Visit | The proportion of participants from each demographic group. |
Countries
United States
Contacts
CONTACTBeatrice Program Manager
CONTACTBrent RN
PRINCIPAL_INVESTIGATORMichael J. Peluso
University of California, San Francisco
Outcome results
None listed