Exploring the Biological Basis of Chronic Fatigue Syndrome

NCT ID: NCT04859257

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 380 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-26
• Study Completion Date: 2021-12-01

Brief Summary

To collect blood and urine samples from patients with Chronic Fatigue Syndrome (CFS), myalgic encephalomyelitis (ME), and SEID (Systemic Exertion Intolerance Syndrome) and controls for genomic, viral and metabolomic testing.

Detailed Description

To analyze gene expression (genomic) and viral analysis data from patients diagnosed with ME/CFS, the study will collect blood samples (finger stick) and information from up to 500 subjects for analysis. In addition, urine will be collected for all subjects to evaluate the study subject's metabolomics.

All participants will complete a single Study Collection event consisting of at least one MCD (2nd sample is optional) and one urine collection from home: 10% of each group (ME/CFS and Control) will complete a second Study Collection event approximately 1 to 2 weeks after the initial Study Collection. The second collection is to compare data between two collections from the same participants to observe any time-related changes in the results.

Conditions

Chronic Fatigue Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Disease Group

Cohort 1 (Disease Group) of the study will collect blood and urine samples from participants who are either diagnosed with Chronic Fatigue Syndrome (CFS) or Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) or experience symptoms of profound fatigue based on the cohort specific inclusion criteria.

No interventions assigned to this group

Control Group

Cohort 2 (Control Group) of the study will collect blood and urine samples from participants who have NOT been diagnosed with Chronic Fatigue Syndrome (CFS) or Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) or experience symptoms of profound fatigue based on the cohort specific exclusion criteria.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Male and female patients age 18 or older at the time of consent

2. Have a permanent address in the United States for the duration of the study

3. Have an email address and access to the internet for the duration of the study

4. Able to provide unassisted informed consent

5. Medical Record Consent (optional)

6. Diagnosed with Chronic Fatigue Syndrome (CFS) or Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) OR

7. Report experiencing one or more of the following symptoms (record all that apply):

1. Greatly lowered ability to perform normal daily activities due to profound fatigue that has lasted for at least 6 months

2. Worsening of (fatigue) symptoms after physical or mental activity that would not have caused a problem before illness (post-exertional malaise).

3. Sleep Problems. Feel overly tired or unrefreshed even after a full night of sleep

4. Problems with thinking and memory (trouble thinking quickly, remembering things, paying attention to details, have "brain fog") OR

5. Worsening of symptoms while standing or sitting upright -

1. Male and female patients age 18 or older at the time of consent

2. Have a permanent address in the United States for the duration of the study

3. Have an email address and access to the internet for the duration of the study

4. Able to provide unassisted informed consent

5. Medical Record Consent (optional)

Exclusion Criteria

• Pregnancy

1. Pregnant

2. Diagnosed with Chronic Fatigue Syndrome (CFS) or Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) OR

3. Report experiencing one or more of the following symptoms (record all that apply):

1. Greatly lowered ability to perform normal daily activities due to profound fatigue that has lasted for at least 6 months

2. Worsening of (fatigue) symptoms after physical or mental activity that would not have caused a problem before illness (post-exertional malaise).

3. Sleep Problems. Feel overly tired or unrefreshed even after a full night of sleep

4. Problems with thinking and memory (trouble thinking quickly, remembering things, paying attention to details, have "brain fog") OR

5. Worsening of symptoms while standing or sitting upright

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DxTerity Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

DxTerity Diagnostics Inc.

Compton, California, United States

Countries

United States

Other Identifiers

DXT-MCD-AH01

Identifier Type: -

Identifier Source: org_study_id