Tracking infections and inflammation in people with ME/CFS
Official title: Chronic Infections and Inflammation in ME/CFS: An Observational Study
Run by University of California, San Francisco · NCT07227441 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | September 2030 |
| Study ends | September 2030 |
| Registry record updated | March 6, 2026 |
| Trial ID | NCT07227441 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.