NCT04224662WithdrawnNot Applicable
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Gout
ProgenaBiome1 site in 1 country100 target enrollmentStarted: March 2, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Correlation of Microbiome to Disease 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.
Detailed Description
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Gout
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study i. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
- •Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome)
- •Diagnosis of Gout by a physician
Exclusion Criteria
- •Refusal to sign informed consent form
- •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
Outcomes
Primary Outcomes
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
Time Frame: Three 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 categorized with Gout
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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