INS, B Cells and Microbiota

Recruiting

• Conditions: Microbiota; T-lymphocytes; B-lymphocytes; Glomerulosclerosis
• Interventions: Other: Measurement of blood immune populations and microbiota distribution.

• Registration Number: NCT04924712
• Lead Sponsor: Nantes University Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-14
• Study Start: 2022-01-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2026-01-18
• Study Completion: 2026-01-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with nephrotic syndrome no idiopathic, IgA or GEM type	Measurement of blood immune populations and microbiota distribution.	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.
Patient with nephrotic syndrome idiopathic	Measurement of blood immune populations and microbiota distribution.	20 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.

Primary Outcome Measures

Name	Time	Method
Sequencing and analysis of intestinal microbiota	3 months	The microbiota will be analyzed using DNA extracted from fecal samples.
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 urinary microbiota	3 months	The microbiota will be analyzed using DNA extracted from urine samples.

Secondary Outcome Measures

Name	Time	Method
Compare blood peripheral immune populations in patients with SNI to that of type SN patients.	3 months	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.
Compare intestinal microbiota in patients with SNI to that of type SN patients.	3 months	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
Compare urine microbiota in patients with SNI to that of type SN patients.	3 months	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

Trial Locations

Locations (2)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France

Departemental Hospital Center; 🇫🇷 La Roche-sur-Yon, France