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

P

ProgenaBiome

Status

Unknown

Conditions

Lupus Erythematosus, Systemic
Lupus Erythematosus

Treatments

Other: No Intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04213690
PRG-033

Details and patient eligibility

About

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Full description

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Lupus.

Enrollment

100 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Patients with Lupus
Description:
Patients who have been diagnosed with Lupus
Treatment:
Other: No Intervention

Trial contacts and locations

0

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Central trial contact

Sabine Hazan, MD; Jordan Daniels, MS

Data sourced from clinicaltrials.gov

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