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

Recruiting

• Conditions: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

• Registration Number: NCT07227441
• Lead 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.

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 Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-10
• Study First Submitted QC: 2025-11-10
• Last Update Submitted: 2025-11-10
• Study First Posted: 2025-11-12
• Last Update Posted: 2025-11-12
• Study Start: 2026-01-01
• Primary Completion: 2030-09
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Zuckerberg San Francisco General Hospital; 🇺🇸 San Francisco, California, United States