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

NCT ID: NCT05132621

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-30

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Systemic Lupus Erythematosus Immunoglobulin A Nephropathy

Keywords

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microbiome systemic lupus erythematosus IgA nephropathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Participants diagnosed with SLE

Smear

Intervention Type DIAGNOSTIC_TEST

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

Participants diagnosed with IgA nephropathy

Smear

Intervention Type DIAGNOSTIC_TEST

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

Healthy Participants

Smear

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Smear

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dept. of Immunology, Transplantology and Internal Medicine Transplantation Institute, Warsaw Medical University

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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SLEIGA-1

Identifier Type: -

Identifier Source: org_study_id