Systemic Lupus ErythematosusNCT05132621
The Genital Tract Microflora in Women With Systemic Lupus Erythematosus (SLE) and Immunoglobulin A (IgA) Nephropathy.
An observational study of Systemic Lupus Erythematosus and Immunoglobulin A Nephropathy, run by Medical University of Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Systemic Lupus Erythematosus, Immunoglobulin A Nephropathy
- What is being tested?
- Smear
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2021to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Lack of menstruation,
- Pregnancy,
- Active infection requiring parenteral or topical antibiotic therapy within 2 weeks before examination,
- Neoplastic disease of the reproductive tract.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Dept. of Immunology, Transplantology and Internal Medicine Transplantation Institute, Warsaw Medical University
Warsaw
About this study
Official title: The Genital Tract Microflora in Women With Systemic Lupus Erythematosus and IgA Nephropathy.
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.
Read more
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.
- Being tested
- Smear
- Keywords
- microbiome, systemic lupus erythematosus, IgA nephropathy
- Medical subject headings
- Lupus Erythematosus, Systemic, Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmearDiagnostic test
A smear of the posterior vaginal fornix collected with a gynecological speculum.
| Study group | Role | What they receive |
|---|---|---|
| Participants diagnosed with SLE | Not described Receives: Diagnostic Test: Smear | |
| Participants diagnosed with IgA nephropathy | Not described Receives: Diagnostic Test: Smear | |
| Healthy Participants | Not described Receives: Diagnostic Test: Smear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in microflora composition between groups of study participants
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132621
- Sponsor's protocol ID
- SLEIGA-1
- Status last verified
- Nov 2021
- First submitted
- 22 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Genital Tract Microflora in Women With Systemic Lupus Erythematosus and IgA Nephropathy.
- ClinicalTrials.gov ID
- NCT05132621
- Acronym / sponsor ID
- SLEIGA-1
- Keywords
- microbiome, systemic lupus erythematosus, IgA nephropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants diagnosed with SLE | – | Diagnostic Test: Smear |
| Participants diagnosed with IgA nephropathy | – | Diagnostic Test: Smear |
| Healthy Participants | – | Diagnostic Test: Smear |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Lack of menstruation,
- Pregnancy,
- Active infection requiring parenteral or topical antibiotic therapy within 2 weeks before examination,
- Neoplastic disease of the reproductive tract.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmearA smear of the posterior vaginal fornix collected with a gynecological speculum. | Diagnostic test | Healthy Participants, Participants diagnosed with IgA nephropathy, Participants diagnosed with SLE |
Primary outcome
Differences in microflora composition between groups of study participants
Time frame: Two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus and Immunoglobulin A Nephropathy, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in microflora composition between groups of study participants (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.