Controlled Multicenter Epidemiological Study of Peripheral Leukocyte Populations and Microbiota in Patients With Idiopathic Nephrotic Syndrome (INS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Nantes University Hospital
- Enrollment
- 30
- Locations
- 4
- Primary Endpoint
- Sequencing and analysis of intestinal microbiota
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Exclusion Criteria
- Not provided
Arms & Interventions
Patient with nephrotic syndrome idiopathic
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.
Intervention: Measurement of blood immune populations and microbiota distribution. (Other)
Patient with nephrotic syndrome no idiopathic, IgA or GEM type or other glomerulopathy
At least 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.
Intervention: Measurement of blood immune populations and microbiota distribution. (Other)
Outcomes
Primary Outcomes
Sequencing and analysis of intestinal microbiota
Time Frame: 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
Time Frame: 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
Time Frame: 3 months
The microbiota will be analyzed using DNA extracted from urine samples.
Secondary Outcomes
- Compare blood peripheral immune populations in patients with SNI to that of type SN patients.(3 months)
- Compare intestinal microbiota in patients with SNI to that of type SN patients.(3 months)
- Compare urine microbiota in patients with SNI to that of type SN patients.(3 months)