INS, B Cells and Microbiota

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-18

Study Completion Date

2026-01-18

Brief Summary

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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

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Detailed Description

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Conditions

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Microbiota B-lymphocytes Glomerulosclerosis T-lymphocytes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with nephrotic syndrome idiopathic

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.

Measurement of blood immune populations and microbiota distribution.

Intervention Type OTHER

Measurement of peripheral cell populations by spectral cytometry and in parallel, sequencing of intestinal and urinary bacterial 16S RNA of each patient.

Patient with nephrotic syndrome no idiopathic, IgA or GEM type

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.

Measurement of blood immune populations and microbiota distribution.

Intervention Type OTHER

Measurement of peripheral cell populations by spectral cytometry and in parallel, sequencing of intestinal and urinary bacterial 16S RNA of each patient.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

* 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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No