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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04100915
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

ProgenaBiome
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sabine Hazan, MD
Principal Investigator Affiliation ProgenaBiome
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myalgic Encephalomyelitis, Chronic Fatigue Syndrome
Additional Details

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).

Arms & Interventions

Arms

: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

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

Interventions

Other: - No Intervention

There is no intervention for this study

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

ProgenaBiome, Ventura, California

Status

Recruiting

Address

ProgenaBiome

Ventura, California, 93003

Site Contact

Sabine Hazan, MD

[email protected]

805-339-0549