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

NCT ID: NCT07227441

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2030-09-30

Brief Summary

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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

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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.

Conditions

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Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Keywords

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ME/CFS myalgic encephalomyelitis chronic fatigue syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-COVID ME/CFS

Individuals who received a diagnosis of ME/CFS prior to the beginning of SARS-CoV-2 pandemic and whom SARS-CoV-2 was not expected to be the driver of ME/CFS

No interventions assigned to this group

Post-COVID ME/CFS

Individuals who received a diagnosis of ME/CFS following the beginning of the SARS-CoV-2 pandemic and in who SARS-CoV-2 was expected to be the driver of ME/CFS

No interventions assigned to this group

Healthy control

Individuals who have overlapping demographic characteristics (age, sex, race, and other factors determined by PI) with participants who have ME/CFS

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael J. Peluso

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Beatrice Program Manager

Role: CONTACT

Phone: (415) 502-2449

Email: [email protected]

Brent RN

Role: CONTACT

Email: [email protected]

Other Identifiers

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24-43260

Identifier Type: -

Identifier Source: org_study_id