WithdrawnNot Applicable

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in ME/CFS

Stopped: Company focus shifted

United States0Started 2020-03-02

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Correlation of Microbiome to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) via Relative Abundance Found in Microbiome Sequencing

Timeframe: 1 year

Trial details

NCT IDNCT04100915

SponsorProgenaBiome

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-03

View on ClinicalTrials.gov More Myalgic Encephalomyelitis trials