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

• Conditions: Immunoglobulin A Nephropathy; Systemic Lupus Erythematosus
• Interventions: Diagnostic Test: Smear

• Registration Number: NCT05132621
• Lead Sponsor: Medical University of Warsaw

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11
• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-11-22
• Last Update Submitted: 2021-11-22
• Study First Posted: 2021-11-24
• Last Update Posted: 2021-11-24
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Participants	Smear	-
Participants diagnosed with SLE	Smear	-
Participants diagnosed with IgA nephropathy	Smear	-

Primary Outcome Measures

Name	Time	Method
Differences in microflora composition between groups of study participants	Two months

Trial Locations

Locations (1)

Dept. of Immunology, Transplantology and Internal Medicine Transplantation Institute, Warsaw Medical University; 🇵🇱 Warsaw, Poland