A Non-Interventional Pilot Study to Explore the Role of Gut Flora in ME/CFS
Reason given: Company focus shifted
Key facts
- Where
- Ventura, United StatesSee the site
Where in United States
- ProgenaBiomeVentura, United StatesNo longer taking part
Trial details
- Who runs it
- ProgenaBiome
- Trial code
- NCT04100915
- Record updated
- 5 June 2025
- Original description
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).Read full original descriptionShow less
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
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).
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: Treatment with antibiotics within 2 weeks prior to screening; Treatment with probiotics within 6 weeks prior to screening; Participation in any experimental drug protocol within the past 12 weeks; Treatment with total parenteral nutrition; History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy; Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial; Refusal by patient to sign informed consent form; Postoperative stoma, ostomy, or ileoanal pouch; Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire stud.