NCT04924712

INS, B Cells and Microbiota

Controlled Multicenter Epidemiological Study of Peripheral Leukocyte Populations and Microbiota in Patients With Idiopathic Nephrotic Syndrome (INS)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Conditions

• Microbiota
• B-lymphocytes
• Glomerulosclerosis
• T-lymphocytes

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2022-01-18
• Primary completion: 2027-01-18
• Completion: 2027-01-18
• First posted: 2021-06-14
• Last updated: 2026-03-03

Locations

2 sites across 1 country: France