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

Withdrawn before enrolling

Conditions studied: Myalgic Encephalomyelitis, Chronic Fatigue Syndrome

In brief

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).

Key facts

Study ID

NCT04100915

Run by

ProgenaBiome

People needed

0

Starts

2020-03-02

Expected to finish

2030-07-01

Last updated by the study team

2025-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ProgenaBiome — Ventura, California, United States

Full record on ClinicalTrials.gov

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