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NCT07227441 | RECRUITING | Myalgic Encephalomyelitis/Chronic Fatigue Syndrome


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

University of California, San Francisco

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.

Condition or disease

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 200 participants
Official Title : Chronic Infections and Inflammation in ME/CFS: An Observational Study
Actual Study Start Date : 2026-01-01
Estimated Primary Completion Date : 2030-09
Estimated Study Completion Date : 2030-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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

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

Location Details

NCT07227441


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Locations


RECRUITING

United States, California

Zuckerberg San Francisco General Hospital

San Francisco, California, United States, 94110

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