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

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Brief Title

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

Official Title

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

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).
    

Detailed Description

      The goal of this Research Study is to better understand how the genetic information in
      subject's microbiome correlates to the information provided in surveys and in medical records
      regarding Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).
    


Study Type

Observational [Patient Registry]


Primary Outcome

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

Secondary Outcome

 Validation of Sequencing Methods

Condition

Myalgic Encephalomyelitis

Intervention

No Intervention

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

25

Start Date

March 2, 2020

Completion Date

July 2023

Primary Completion Date

March 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Signed informed consent by patient

          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:

          1. Refusal by patient to sign informed consent form

          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
      

Gender

All

Ages

18 Years - N/A


Contacts

Sabine Hazan, MD, 8053390549, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04100915

Organization ID

ProgenaBiome-010


Responsible Party

Sponsor

Study Sponsor

ProgenaBiome


Study Sponsor

Sabine Hazan, MD, Principal Investigator, ProgenaBiome


Verification Date

March 2020