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

• Conditions: Lupus Erythematosus, Systemic; Lupus Erythematosus
• Interventions: Other: No Intervention

• Registration Number: NCT04213690
• Lead Sponsor: ProgenaBiome

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.

Study Timeline

• Study First Submitted: 2019-12-27
• Study First Submitted QC: 2019-12-27
• Study First Posted: 2019-12-30
• Study Start: 2020-03-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05
• Primary Completion: 2023-03
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 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

2. 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)

3. Diagnosis of Lupus by a physician

Exclusion Criteria

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Lupus	No Intervention	Patients who have been diagnosed with Lupus

Primary Outcome Measures

Name	Time	Method
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing	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

Trial Locations

Locations (1)

ProgenaBiome; 🇺🇸 Ventura, California, United States