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Recruiting Observational

INS, B Cells and Microbiota

NCT04924712 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2022-01-18
Last updated
2026-03-03

Condition(s) studied

MicrobiotaB-lymphocytesGlomerulosclerosisT-lymphocytes

Investigational drug(s) / intervention(s)

Measurement of blood immune populations and microbiota distribution.

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.

Study 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

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Sequencing and analysis of blood peripheral immune populations and intestinal and urinary microbiota — 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 — 3 months
    The microbiota will be analyzed using DNA extracted from fecal samples.
  • Sequencing and analysis of urinary microbiota — 3 months
    The microbiota will be analyzed using DNA extracted from urine samples.

Trial sites (2)

FacilityCityRegionStatus
Nantes University Hospital Nantes Loire-Atlantique Recruiting
Departemental Hospital Center La Roche-sur-Yon France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04924712 on ClinicalTrials.gov ↗ ← All trials in France