Chronic Infections and Inflammation in ME/CFS: An Observa... | NCT07227441

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

NCT07227441

Sponsor

University of California, San Francisco

Status

Recruiting

Last Update Posted

Mar 6, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2026Actual

Primary Completion Date

Sep 2030Estimated

Completion Date

Sep 2030Estimated

First Submitted Date

Nov 10, 2025

First Submission Date that Met QC Criteria

Nov 10, 2025

First Posted Date

Nov 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2026

Last Update Posted Date

Mar 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
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
Healthy control		Individuals who have overlapping demographic characteristics (age, sex, race, and other factors determined by PI) with participants who have ME/CFS

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participant Sex	The proportion of men and women participating in the baseline visit.	Baseline Visit
Participant Age	The median age of study participants at enrollment.	Baseline Visit
Participant race/ethnicity	The proportion of participants from each demographic group.	Baseline Visit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The investigators will enroll individuals with a diagnosis of ME/CFS across a wide spectrum of age, race, gender, and disease severity and will also enroll a subset of people without ME/CFS or other infection associated chronic conditions (healthy control)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Beatrice Program Manager	Contact	(415) 502-2449		chiime@ucsf.edu
Brent RN	Contact			chiime@ucsf.edu

Overall Officials

Name	Affiliation	Role
Michael J. Peluso	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zuckerberg San Francisco General Hospital	Recruiting	San Francisco	California	94110	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015673	Fatigue Syndrome, Chronic

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D004679	Encephalomyelitis
D000090862	Neuroinflammatory Diseases

Browse Leaves

Not provided

Browse Branches

Not provided