Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04100915
Other study ID # PRG-010
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05454683 - Melatonin and Zinc Administration on Cardinal Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome N/A
Completed NCT02075489 - Acupressure for Pain Management and Fatigue Relief in Gulf War Veterans N/A
Completed NCT01686074 - Motor Control in Chronic Fatigue Syndrome and Fibromyalgia N/A
Completed NCT01651754 - Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome N/A
Completed NCT00540254 - Behavioral Insomnia Therapy With Chronic Fatigue Syndrome Phase 1/Phase 2
Active, not recruiting NCT00071162 - Genetics of Fibromyalgia N/A
Withdrawn NCT04870476 - Feasibility and Acceptability of the Internet-delivered Treatment "One Step at the Time" for Bodily Distress Syndrome N/A
Completed NCT05730660 - Quercetin Phytosome® Chronic Fatigue Syndrome N/A
Recruiting NCT04542161 - Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Phase 2
Recruiting NCT03807973 - Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes. Phase 1
Recruiting NCT05719493 - Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +) N/A
Recruiting NCT05967052 - Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation Phase 2
Terminated NCT01730495 - Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome Phase 2
Completed NCT01156909 - B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome Phase 2
Completed NCT01650636 - Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process N/A
Completed NCT01046370 - A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia N/A
Completed NCT00100412 - Hyporeactivity and Gulf War Illness N/A
Recruiting NCT06128967 - A Multicenter, Adaptive, Randomized, doublE-blinded, Placebo-controlled Study in Participants With Long COVID-19: The REVIVE Trial Phase 3
Completed NCT02669212 - Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health N/A
Not yet recruiting NCT06011135 - Exploring Worry in CFS/ME