Chronic Infections and Inflammation in ME/CFS: An Observational Study (CHIIME)

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT07227441

24-43260

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 3 patient groups

Non-COVID ME/CFS

Description:

Individuals who received a diagnosis of ME/CFS prior to the beginning of SARS-CoV-2 pandemic and whom SARS-CoV-2 was not expected to be the driver of ME/CFS

Post-COVID ME/CFS

Description:

Individuals who received a diagnosis of ME/CFS following the beginning of the SARS-CoV-2 pandemic and in who SARS-CoV-2 was expected to be the driver of ME/CFS

Healthy control

Description:

Individuals who have overlapping demographic characteristics (age, sex, race, and other factors determined by PI) with participants who have ME/CFS