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NCT Number: NCT07227441

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

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Participant Sex

    Time frame: Baseline Visit

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

  2. Participant Age

    Time frame: Baseline Visit

    The median age of study participants at enrollment.

  3. Participant race/ethnicity

    Time frame: Baseline Visit

    The proportion of participants from each demographic group.

Study contacts

Contact information is provided by the study sponsor or research team.

Beatrice Program Manager

CONTACT

[email protected]

(415) 502-2449

Brent RN

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: CHIIME

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Nov 12, 2025
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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