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

Sponsor
ProgenaBiome (Other)
Overall Status
Recruiting
CT.gov ID
NCT04100915
Collaborator
(none)
25
1
40
0.6

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: No Intervention

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
25 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Actual Study Start Date :
Mar 2, 2020
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

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

Other: No Intervention
There is no intervention for this study

Outcome Measures

Primary Outcome Measures

  1. Correlation of Microbiome to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) via Relative Abundance Found in Microbiome Sequencing [1 year]

    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)

Secondary Outcome Measures

  1. Validation of Sequencing Methods [1 year]

    To validate the methods used to sequence samples

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ProgenaBiome Ventura California United States 93003

Sponsors and Collaborators

  • ProgenaBiome

Investigators

  • Principal Investigator: Sabine Hazan, MD, ProgenaBiome

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ProgenaBiome
ClinicalTrials.gov Identifier:
NCT04100915
Other Study ID Numbers:
  • PRG-010
First Posted:
Sep 24, 2019
Last Update Posted:
Sep 5, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021