NCT04214548WithdrawnNot Applicable
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Eczema
ProgenaBiome1 site in 1 country25 target enrollmentStarted: March 2, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Correlation of Microbiome to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) via Relative Abundance Found in Microbiome Sequencing
Study Overview
Brief Summary
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding eczema.
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 eczema.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed informed consent by patient
- •Male or female patients age 18 and older.
- •Diagnosis of eczema
Exclusion Criteria
- •Refusal by patient to sign informed consent form
- •Treatment with antibiotics within 2 weeks prior to screening
- •Treatment with probiotics within 6 weeks prior to screening
- •History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
- •Postoperative stoma, ostomy, or ileoanal pouch
- •Participation in any experimental drug protocol within the past 12 weeks
- •Treatment with total parenteral nutrition
- •Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
- •Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire stud
Outcomes
Primary Outcomes
Correlation of Microbiome to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) via Relative Abundance Found in Microbiome Sequencing
Time Frame: 3 years
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 Outcomes
- Validation of Sequencing Methods(3 years)
Investigators
Study Sites (1)
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