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

University of California, San Francisco200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

Participant Sex

The proportion of men and women participating in the baseline visit.

Time frame: Baseline Visit

Participant Age

The median age of study participants at enrollment.

Time frame: Baseline Visit

Participant race/ethnicity

The proportion of participants from each demographic group.

Time frame: Baseline Visit

Central Contacts

Beatrice Program Manager

CONTACT

(415) 502-2449 chiime@ucsf.edu

Brent RN

CONTACT

chiime@ucsf.edu

Data from ClinicalTrials.gov

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