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

NCT07227441 | Recruiting

• 1 other identifier: 24-43260
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Keywords

ME/CFS; myalgic encephalomyelitis; chronic fatigue syndrome

Outcome Measures

Primary Outcomes (3)

• Participant Sex

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

  Baseline Visit

• Participant Age

  The median age of study participants at enrollment.

  Baseline Visit

• Participant race/ethnicity

  The proportion of participants from each demographic group.

  Baseline Visit

Study Arms (3)

Non-COVID ME/CFS

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, peripheral blood mononuclear cells, plasma, serum, nasal swab, stool, and saliva

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael J. Peluso

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatrice Program Manager

CONTACT

(415) 502-2449; chiime@ucsf.edu

Brent RN

CONTACT

chiime@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2025
• First Posted: November 12, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)