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

ProgenaBiome

Status: Withdrawn

Conditions: Myalgic Encephalomyelitis; Chronic Fatigue Syndrome

Treatments: Other: No Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04100915

PRG-010

Details and patient eligibility

About

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).

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Description:

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

Treatment:

Other: No Intervention