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

Chronic Fatigue Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04100915
• Other study ID #: PRG-010
• Status: Recruiting
• Start date: March 2, 2020
• Est. completion date: July 2023

Study information

• Verified date: September 2021
• Source: ProgenaBiome
• Contact: Sabine Hazan, MD
• Phone: 18053390549
• Email: drsabinehazan[@]progenabiome.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 2023
• Est. primary completion date: March 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Encephalomyelitis
• Fatigue
• Fatigue Syndrome, Chronic
• Myalgia
• Myalgic Encephalomyelitis
• Syndrome

Intervention

Other:
• No Intervention
There is no intervention for this study

Locations

Country	Name	City	State
United States	ProgenaBiome	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
ProgenaBiome

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Validation of Sequencing Methods	To validate the methods used to sequence samples	1 year