NCT05132621

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

November 22, 2021

Last Update Submit

November 22, 2021

Conditions

Systemic Lupus ErythematosusImmunoglobulin A Nephropathy

Keywords

microbiomesystemic lupus erythematosusIgA nephropathy

Outcome Measures

Primary Outcomes (1)

  • Differences in microflora composition between groups of study participants

    Two months

Study Arms (3)

Participants diagnosed with SLE

Diagnostic Test: Smear

Participants diagnosed with IgA nephropathy

Diagnostic Test: Smear

Healthy Participants

Diagnostic Test: Smear

Interventions

SmearDIAGNOSTIC_TEST

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

Healthy ParticipantsParticipants diagnosed with IgA nephropathyParticipants diagnosed with SLE

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsA study based on the analysis of genital tract microflora of women of reproductive age.
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50 participants diagnosed with SLE and 50 participants diagnosed with IgA nephropathy will be included in the study. The control group will consist of 50 healthy participants.

You may qualify if:

  • 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.

You may not qualify if:

  • Lack of menstruation,
  • Pregnancy,
  • Active infection requiring parenteral or topical antibiotic therapy within 2 weeks before examination,
  • Neoplastic disease of the reproductive tract.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Warsaw, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Vaginal secretion

MeSH Terms

Conditions

Lupus Erythematosus, SystemicGlomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesGlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2021

First Posted

November 24, 2021

Study Start

November 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

November 24, 2021

Record last verified: 2021-11

Locations

PL(1)