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Status unknownNCT05132621Updated Nov 24, 2021

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

An observational study in Systemic Lupus Erythematosus and Immunoglobulin A Nephropathy, sponsored by Medical University of Warsaw. Status unknown at 1 site in Poland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-24.

Sponsored by Medical University of Warsaw · Observational

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years and older
Sex
Female
01

Study 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.

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Conditions studied

  • Systemic Lupus Erythematosus
  • Immunoglobulin A Nephropathy

Keywords

  • microbiome
  • systemic lupus erythematosus
  • IgA nephropathy
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In context

Lupus Erythematosus, Systemic

1,222 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 150 is close to the median of 149 across 287 observational studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Medical University of Warsaw is the lead sponsor of 325 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Participants diagnosed with SLE

    Diagnostic Test: Smear

  • Participants diagnosed with IgA nephropathy

    Diagnostic Test: Smear

  • Healthy Participants

    Diagnostic Test: Smear

Interventions

  • Diagnostic testSmear

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

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What researchers measure

Primary outcomes

  1. Differences in microflora composition between groups of study participants

    Time frame: Two months

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Study locations

1 site
  • Dept. of Immunology, Transplantology and Internal Medicine Transplantation Institute, Warsaw Medical University
    Warsaw, Poland
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2021; primary completion for Dec 2022, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2021
First posted
Nov 24, 2021
StartEst.
Nov 2021
Primary completionEst.
Dec 2022
CompletionEst.
Dec 2023
Last update
Nov 24, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05132621
Responsible party
Sponsor
First posted
Nov 24, 2021
Start date
Nov 2021 (estimated)
Primary completion
Dec 2022 (estimated)
Completion
Dec 2023 (estimated)
Last update
Nov 24, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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