Skip to main content
Clinical Trials/NCT04213690
NCT04213690
Withdrawn
Not Applicable

A Pilot Study to Explore the Role of Gut Flora in Lupus

ProgenaBiome1 site in 1 country100 target enrollmentMarch 2, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lupus Erythematosus
Sponsor
ProgenaBiome
Enrollment
100
Locations
1
Primary Endpoint
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
Status
Withdrawn
Last Updated
11 months ago

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 Lupus.

Registry
clinicaltrials.gov
Start Date
March 2, 2020
End Date
July 2030
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
ProgenaBiome
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
  • a. 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 Lupus 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 Lupus

Study Sites (1)

Loading locations...

Similar Trials