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

NCT04100915 | Withdrawn DMC

• 1 other identifier: PRG-010
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Myalgic Encephalomyelitis; Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

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

  Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be correlated to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

  1 year

Secondary Outcomes (1)

• Validation of Sequencing Methods

  1 year

Study Arms (1)

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Patients diagnosed with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

Other: No Intervention

Interventions

No Intervention OTHER

There is no intervention for this study

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

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

Sponsors & Collaborators

• ProgenaBiome: lead

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool Samples

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sabine Hazan, MD

  ProgenaBiome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: March 2, 2020
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

US (1)