Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorUniversity of California, San Francisco
Academic / other
Locations1 site (San Francisco, California)
StatusRecruiting
StartedJanuary 1, 2026
Main results expectedSeptember 2030
Study endsSeptember 2030
Registry record updatedMarch 6, 2026
Trial IDNCT07227441 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

  • 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

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.