INS, B Cells and Microbiota

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorNantes University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient treated in participating centers

Patient with a history of NIS flare-ups resistant to corticosteroid therapy

Patient treated with immunosuppressant

Patient treated with corticosteroids > 10 mg/d

Disqualifiers

None

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Measurement of blood immune populations and microbiota distribution.

    Other intervention

    Measurement of peripheral cell populations by spectral cytometry and in parallel, sequencing of intestinal and urinary bacterial 16S RNA of each patient.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Patient with nephrotic syndrome idiopathic1 intervention
Group B: Patient with nephrotic syndrome no idiopathic, IgA or GEM type or other glomerulopathy1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months
2

Sequencing and analysis of intestinal microbiota

The microbiota will be analyzed using DNA extracted from fecal samples.

Time frame
3 months
3

Sequencing and analysis of urinary microbiota

The microbiota will be analyzed using DNA extracted from urine samples.

Time frame
3 months

Secondary outcomes

1

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.

Time frame
3 months
2

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

Time frame
3 months
3

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

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.