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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05132621
• Other study ID #: SLEIGA-1
• Status: Enrolling by invitation
• Start date: November 2021
• Est. completion date: December 2023

Study information

• Verified date: November 2021
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• Immunoglobulin A Nephropathy
• Kidney Diseases
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Diagnostic Test:
• Smear
A smear of the posterior vaginal fornix collected with a gynecological speculum.

Locations

Country	Name	City	State
Poland	Dept. of Immunology, Transplantology and Internal Medicine Transplantation Institute, Warsaw Medical University	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in microflora composition between groups of study participants		Two months