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

ConditionMyalgic Encephalomyelitis/Chronic Fatigue Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

The investigators will enroll individuals with a diagnosis of ME/CFS across a wide spectrum of age, race, gender, and disease severity and will also enroll a subset of people without ME/CFS or other infection associated chronic conditions (healthy control)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 3 trial groups
Group A: Non-COVID ME/CFS
Group B: Post-COVID ME/CFS
Group C: Healthy control

Trial outcomes

Primary outcomes

1

Participant Sex

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

Time frame
Baseline Visit
2

Participant Age

The median age of study participants at enrollment.

Time frame
Baseline Visit
3

Participant race/ethnicity

The proportion of participants from each demographic group.

Time frame
Baseline Visit

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov
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