NCT05132621

The Genital Tract Microflora in Women With Systemic Lupus Erythematosus (SLE) and Immunoglobulin A (IgA) Nephropathy.

The Genital Tract Microflora in Women With Systemic Lupus Erythematosus and IgA Nephropathy.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

The study hypothesis: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a broad spectrum of clinical manifestations. Its mechanisms are not well understood. It is known that its development is influenced by genetic factors and gender. However, it is believed that in some patients with a specific genetic predisposition, certain environmental factors such as chemicals, including drugs and toxins, smoking, or infections may initiate the development of the disease. Of particular importance seem to be infections, which by stimulating the immune system can induce new symptoms or exacerbate existing ones. For this reason, links between the microbiome and the clinical course of SLE are being sought. Most available studies concern the intestinal microbiome. So far, the relationship between the genital tract microbiota and the clinical picture of SLE has not been documented. Aim of the study: This study aims to identify and differentiate the genital tract microbiota of women with a diagnosis of systemic lupus, IgA nephropathy and a control group of healthy women. The results will be correlated with the clinical presentation of these diseases. In addition, the isolated bacterial strains will be secured for further study.

Conditions

• Systemic Lupus Erythematosus
• Immunoglobulin A Nephropathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Smear	A smear of the posterior vaginal fornix collected with a gynecological speculum.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2021-11-24
• Last updated: 2021-11-24

Locations

1 site across 1 country: Poland