Clinical trial NCT04924712: INS, B Cells and Microbiota
Official title: Controlled Multicenter Epidemiological Study of Peripheral Leukocyte Populations and Microbiota in Patients With Idiopathic Nephrotic Syndrome (INS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Microbiota
B-lymphocytes
Glomerulosclerosis
T-lymphocytes
Keywords: Idiopathic Nephrotic Syndrome
Focal Segmental Glomerulosclerosis
Microbiota
B Lymphocytes
Regulatory T cells
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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 will be integrated into the control group for the secondary objectivets

Brief 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). 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: Inclusion Criteria :

* 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
* Patient treated with corticosteroids \> 10 mg/d
* Weight \<50 kg
* Pregnant woman
* Patient under guardianship / curatorship

Primary outcomes:
measure: Sequencing and analysis of blood peripheral immune populations and intestinal and urinary microbiota
timeFrame: 3 months
measure: Sequencing and analysis of intestinal microbiota
timeFrame: 3 months
measure: Sequencing and analysis of urinary microbiota
timeFrame: 3 months
Secondary outcomes:
measure: Compare blood peripheral immune populations in patients with SNI to that of type SN patients.
timeFrame: 3 months
measure: Compare intestinal microbiota in patients with SNI to that of type SN patients.
timeFrame: 3 months
measure: Compare urine microbiota in patients with SNI to that of type SN patients.
timeFrame: 3 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
city: La Roche-sur-Yon
country: France
facility: Departemental Hospital Center
Study officials:
References: