The Genital Tract Microflora in Women With Systemic Lupus Erythematosus (SLE) and Immunoglobulin A (IgA) Nephropathy.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants diagnosed with SLE
|
Diagnostic Test: Smear
A smear of the posterior vaginal fornix collected with a gynecological speculum.
|
| Participants diagnosed with IgA nephropathy
|
Diagnostic Test: Smear
A smear of the posterior vaginal fornix collected with a gynecological speculum.
|
| Healthy Participants
|
Diagnostic Test: Smear
A smear of the posterior vaginal fornix collected with a gynecological speculum.
|
Outcome Measures
Primary Outcome Measures
- Differences in microflora composition between groups of study participants [Two months]
Eligibility Criteria
Criteria
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:
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Lack of menstruation,
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Pregnancy,
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Active infection requiring parenteral or topical antibiotic therapy within 2 weeks before examination,
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Neoplastic disease of the reproductive tract.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dept. of Immunology, Transplantology and Internal Medicine Transplantation Institute, Warsaw Medical University | Warsaw | Poland |
Sponsors and Collaborators
- Medical University of Warsaw
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SLEIGA-1