Tracking infections and inflammation in people with ME/CFS
Chronic Infections and Inflammation in ME/CFS: An Observational Study
This project will try to see if ongoing infections or inflammation are linked to biological changes in adults with ME/CFS by collecting clinical data and biospecimens over time, with healthy volunteers for comparison.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07227441 on ClinicalTrials.gov |
What this trial studies
CHIIME is a prospective observational cohort enrolling adults with ME/CFS and healthy controls at Zuckerberg San Francisco General Hospital. Participants complete detailed interviews, clinical assessments, and serial biospecimen collection for high-quality biobanking. Samples are de-identified and used for molecular, immunologic, and physiological analyses to enable deep clinical phenotyping. The goal is to map biological signatures and clinical trajectories of ME/CFS over time to inform future diagnostic markers and interventions.
Who should consider this trial
Good fit: Adults aged 18 or older with a reported diagnosis of ME/CFS, or healthy adults without infection-associated chronic conditions, who can give informed consent and attend visits at the study site are appropriate candidates.
Not a fit: People with active HIV, hepatitis B or C, chronic anemia (hemoglobin <9 g/dL), other infection-associated chronic conditions, serious medical or psychiatric issues that prevent participation, or active substance dependence are excluded and unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, this work could identify biological markers that improve diagnosis or point to targets for future treatments for people with ME/CFS.
How similar studies have performed: Previous observational cohorts have found immune and physiological differences in ME/CFS but reproducible diagnostic biomarkers remain limited, so this approach builds on prior signals but is not yet proven to change care.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California
- Zuckerberg San Francisco General Hospital — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Michael J. Peluso — University of California, San Francisco
- Study coordinator: Beatrice Program Manager
- Email: chiime@ucsf.edu
- Phone: (415) 502-2449
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.