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Clinical Trials/NCT04214548
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Withdrawn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

Sponsor
ProgenaBiome
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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