Status:
WITHDRAWN
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in ME/CFS
Lead Sponsor:
ProgenaBiome
Conditions:
Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).
Detailed Description
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Myalgic E...
Eligibility Criteria
Inclusion
- Signed informed consent by patient
- Male or female patients age 18 and older.
- Diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) based on the proposed diagnostic criteria of the National Academy of Medicine
Exclusion
- Refusal by patient to sign informed consent form
- Treatment with antibiotics within 2 weeks prior to screening
- Treatment with probiotics within 6 weeks prior to screening
- History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
- Postoperative stoma, ostomy, or ileoanal pouch
- Participation in any experimental drug protocol within the past 12 weeks
- Treatment with total parenteral nutrition
- Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
- Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire stud
Key Trial Info
Start Date :
March 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2030
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04100915
Start Date
March 2 2020
End Date
July 1 2030
Last Update
June 5 2025
Active Locations (1)
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1
ProgenaBiome
Ventura, California, United States, 93003