A Non-Interventional Pilot Study to Explore the Role of Gut Flora in ME/CFS
NCT ID: NCT04100915
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2020-03-02
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Patients diagnosed with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).
No Intervention
There is no intervention for this study
Interventions
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No Intervention
There is no intervention for this study
Eligibility Criteria
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Inclusion Criteria
2. Male or female patients age 18 and older.
3. Diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) based on the proposed diagnostic criteria of the National Academy of Medicine
Exclusion Criteria
2. Treatment with antibiotics within 2 weeks prior to screening
3. Treatment with probiotics within 6 weeks prior to screening
4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
5. Postoperative stoma, ostomy, or ileoanal pouch
6. Participation in any experimental drug protocol within the past 12 weeks
7. Treatment with total parenteral nutrition
8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
9. Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire stud
18 Years
ALL
No
Sponsors
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ProgenaBiome
OTHER
Responsible Party
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Principal Investigators
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Sabine Hazan, MD
Role: PRINCIPAL_INVESTIGATOR
ProgenaBiome
Locations
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ProgenaBiome
Ventura, California, United States
Countries
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Other Identifiers
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PRG-010
Identifier Type: -
Identifier Source: org_study_id
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