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

Medical University of Warsaw

Status

Unknown

Conditions

Immunoglobulin A Nephropathy

Systemic Lupus Erythematosus

Treatments

Diagnostic Test: Smear

Study type

Observational

Funder types

Other

Identifiers

NCT05132621

SLEIGA-1

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >18 years,
Confirmed diagnosis of SLE or IgA nephropathy,
First half of the menstrual cycle, after the end of bleeding,
Signed informed consent to participate in the study.

Exclusion criteria

Lack of menstruation,
Pregnancy,
Active infection requiring parenteral or topical antibiotic therapy within 2 weeks before examination,
Neoplastic disease of the reproductive tract.