MicrobiotaNCT04924712
INS, B Cells and Microbiota
An observational study of Microbiota and B-lymphocytes, run by Nantes University Hospital at 2 sites in France.
Trial summary
Idiopathic nephrotic syndrome (NIS) is a clinical entity defined by the association of selective albuminuria, hypoalbuminemia, and nonspecific glomerular lesions (lesions minimal glomerular (LGM) or segmental and focal hyalinosis (HSF). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Microbiota, B-lymphocytes, Glomerulosclerosis
- What is being tested?
- Measurement of blood immune populations and microbiota distribution.
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Jan 2022to 18 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with idiopathic nephrotic syndrome (LGM or HSF type) will be considered in the main objective, patients with IgA or GEM type nephrotic syndrome or other glomerulopathy will be integrated into the control group for the secondary objectivets
Who may be able to join
- Patient treated in participating centers
- In nephrotic attack, defined biologically by:
- Proteinuria > 3g 24h or A proteinuria/creatinuria ratio > 3 or Defined at the discretion of the clinician
- Non inclusion Criteria :
- Patient with a history of NIS flare-ups resistant to corticosteroid therapy
- Patient treated with immunosuppressant
Show all 10Show fewer
- Patient treated with corticosteroids > 10 mg/d
- Weight <50 kg
- Pregnant woman
- Patient under guardianship / curatorship
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Departemental Hospital Center
La Roche-sur-Yon, 85925
Awena LEFUR, 0251446161, awena.lefur@ght85.fr
- Recruiting
Nantes University Hospital
Nantes, Loire-Atlantique, 44093
About this study
Official title: Controlled Multicenter Epidemiological Study of Peripheral Leukocyte Populations and Microbiota in Patients With Idiopathic Nephrotic Syndrome (INS)
Idiopathic nephrotic syndrome (NIS) is a clinical entity defined by the association of selective albuminuria, hypoalbuminemia, and nonspecific glomerular lesions (lesions minimal glomerular (LGM) or segmental and focal hyalinosis (HSF). The complication of this kidney disease is the progression towards chronic renal failure and in case of kidney transplantation, its immediate recurrence on the graft . The origin of this syndrome is unknown but a number of clinical observations tend to show an involvement of immune system. A link has been highlighted between atopy, diet and nephrotic flare-ups. The speed of recurrence of this initial disease on the graft and the observation of remissions obtained after treatment by plasma exchange or immunoadsorptions support the presence of a pathogenic plasma factor. Anti-CD20 treatments depleting B lymphocytes has made it possible to favorably treat a number of patients. Dysfunction of regulatory T cells has also been shown in SNI patients. This modification seems linked to allergies and could be due to an aberrant microbiota. The hypothesis of causality between dysbiosis, alteration lymphocyte and triggering of an SNI was mentioned recently. Two studies have shown intestinal dysbiosis in pediatric SNI/LGM, with reduction of T circulating regulators
- Conditions
- Microbiota, B-lymphocytes, Glomerulosclerosis, T-lymphocytes
- Being tested
- Measurement of blood immune populations and microbiota distribution.
- Keywords
- Idiopathic Nephrotic Syndrome, Focal Segmental Glomerulosclerosis, Microbiota, B Lymphocytes, Regulatory T cells
- Medical subject headings
- Nephrosis, Lipoid, Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of blood immune populations and microbiota distribution.Other
Measurement of peripheral cell populations by spectral cytometry and in parallel, sequencing of intestinal and urinary bacterial 16S RNA of each patient.
| Study group | Role | What they receive |
|---|---|---|
| Patient with nephrotic syndrome idiopathic | nephrotic INS patients in primary visit: harvesting of 27.5 ml supplementary blood, 40 mlurine and feces at inclusion visit and at 3 months. No intervention, no treatment administration other than usual/routine INS treatment. Receives: Other: Measurement of blood immune populations and microbiota distribution. | |
| Patient with nephrotic syndrome no idiopathic, IgA or GEM type or other glomerulopathy | At least 10 NS no idipathic patients: harvesting of 27.5 ml supplementary blood, 40 ml urine and feces at inclusion visit and at 3 months. No intervention, no treatment administration other than usual/routine care treatment. Receives: Other: Measurement of blood immune populations and microbiota distribution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequencing and analysis of blood peripheral immune populations and intestinal and urinary microbiota
For the analysis of peripheral populations, blood cells will be collected by density gradient (Ficoll) and frozen in 20% DMSO. They will then be marked and identified by flow cytometry.
Measured: 3 months
Sequencing and analysis of intestinal microbiota
The microbiota will be analyzed using DNA extracted from fecal samples.
Measured: 3 months
Sequencing and analysis of urinary microbiota
The microbiota will be analyzed using DNA extracted from urine samples.
Measured: 3 months
Secondary outcomes (3)
Compare blood peripheral immune populations in patients with SNI to that of type SN patients.
We will collect clinical and biological variables from each patient with a syndrome nephrotic type GEM or IgA as well as the results of the analysis of populations peripheral immune systems.
Measured: 3 months
Compare intestinal microbiota in patients with SNI to that of type SN patients.
We will collect clinical and biological variables from each patient with a syndrome nephrotic type GEM or IgA as well as the results of the analysis of the microbiota
Measured: 3 months
Compare urine microbiota in patients with SNI to that of type SN patients.
We will collect clinical and biological variables from each patient with a syndrome nephrotic type GEM or IgA as well as the results of the analysis of the microbiota
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start18 Jan 2022
- Primary completion18 Jan 2027 (estimated)
- Study completion18 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924712
- Sponsor's protocol ID
- RC21_0118
- Status last verified
- Feb 2026
- First submitted
- 8 Jun 2021
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Multicenter Epidemiological Study of Peripheral Leukocyte Populations and Microbiota in Patients With Idiopathic Nephrotic Syndrome (INS)
- ClinicalTrials.gov ID
- NCT04924712
- Acronym / sponsor ID
- RC21_0118
- Conditions
- Microbiota, B-lymphocytes, Glomerulosclerosis, T-lymphocytes
- Keywords
- Idiopathic Nephrotic Syndrome, Focal Segmental Glomerulosclerosis, Microbiota, B Lymphocytes, Regulatory T cells
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 18 Jan 2027 (estimated)
- Study completion
- 18 Jan 2027 (estimated)
- First posted
- 14 Jun 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.
Idiopathic nephrotic syndrome (NIS) is a clinical entity defined by the association of selective albuminuria, hypoalbuminemia, and nonspecific glomerular lesions (lesions minimal glomerular (LGM) or segmental and focal hyalinosis (HSF). The complication of this kidney disease is the progression towards chronic renal failure and in case of kidney transplantation, its immediate recurrence on the graft . The origin of this syndrome is unknown but a number of clinical observations tend to show an involvement of immune system. A link has been highlighted between atopy, diet and nephrotic flare-ups. The speed of recurrence of this initial disease on the graft and the observation of remissions obtained after treatment by plasma exchange or immunoadsorptions support the presence of a pathogenic plasma factor. Anti-CD20 treatments depleting B lymphocytes has made it possible to favorably treat a number of patients. Dysfunction of regulatory T cells has also been shown in SNI patients. This modification seems linked to allergies and could be due to an aberrant microbiota. The hypothesis of causality between dysbiosis, alteration lymphocyte and triggering of an SNI was mentioned recently. Two studies have shown intestinal dysbiosis in pediatric SNI/LGM, with reduction of T circulating regulators
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with nephrotic syndrome idiopathic | – | Other: Measurement of blood immune populations and microbiota distribution.nephrotic INS patients in primary visit: harvesting of 27.5 ml supplementary blood, 40 mlurine and feces at inclusion visit and at 3 months. No intervention, no treatment administration other than usual/routine INS treatment. |
| Patient with nephrotic syndrome no idiopathic, IgA or GEM type or other glomerulopathy | – | Other: Measurement of blood immune populations and microbiota distribution.At least 10 NS no idipathic patients: harvesting of 27.5 ml supplementary blood, 40 ml urine and feces at inclusion visit and at 3 months. No intervention, no treatment administration other than usual/routine care treatment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with idiopathic nephrotic syndrome (LGM or HSF type) will be considered in the main objective, patients with IgA or GEM type nephrotic syndrome or other glomerulopathy will be integrated into the control group for the secondary objectivets
Key inclusion criteria (10 listed)
- Patient treated in participating centers
- In nephrotic attack, defined biologically by:
- Proteinuria > 3g 24h or A proteinuria/creatinuria ratio > 3 or Defined at the discretion of the clinician
- Patient with a history of NIS flare-ups resistant to corticosteroid therapy
- Patient treated with immunosuppressant
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Measurement of blood immune populations and microbiota distribution.Measurement of peripheral cell populations by spectral cytometry and in parallel, sequencing of intestinal and urinary bacterial 16S RNA of each patient. | Other | Patient with nephrotic syndrome idiopathic, Patient with nephrotic syndrome no idiopathic, IgA or GEM type or other glomerulopathy |
Primary outcome
Sequencing and analysis of blood peripheral immune populations and intestinal and urinary microbiota
Time frame: 3 months
For the analysis of peripheral populations, blood cells will be collected by density gradient (Ficoll) and frozen in 20% DMSO. They will then be marked and identified by flow cytometry.
Sequencing and analysis of intestinal microbiota
Time frame: 3 months
The microbiota will be analyzed using DNA extracted from fecal samples.
Sequencing and analysis of urinary microbiota
Time frame: 3 months
The microbiota will be analyzed using DNA extracted from urine samples.
3 secondary outcomes
Compare blood peripheral immune populations in patients with SNI to that of type SN patients.
Time frame: 3 months
Compare intestinal microbiota in patients with SNI to that of type SN patients.
Time frame: 3 months
Compare urine microbiota in patients with SNI to that of type SN patients.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbiota and B-lymphocytes, run by Nantes University Hospital at 2 sites in France.
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 10 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Masset (+33 2 76 64 39 61, christophe.masset@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sequencing and analysis of blood peripheral immune populations and intestinal and urinary microbiota (time frame: 3 months). The study lists 3 primary outcomes in all. 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 3 Mar 2026.