Chronic Infections and Inflammation in ME/CFS: An Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Primary outcome measures
- Participant Sex [Time frame: Baseline Visit]
- Participant Age [Time frame: Baseline Visit]
- Participant race/ethnicity [Time frame: Baseline Visit]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Zuckerberg San Francisco General Hospital — San Francisco
Identifiers
NCT: NCT07227441 · 24-43260