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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05132621

Enrollment

150

Registered

2021-11-24

Start date

2021-11-30

Completion date

2023-12-31

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus, Immunoglobulin A Nephropathy

Keywords

microbiome, systemic lupus erythematosus, IgA nephropathy

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.

Interventions

DIAGNOSTIC_TESTSmear

A smear of the posterior vaginal fornix collected with a gynecological speculum.

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Differences in microflora composition between groups of study participants	Two months

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026