Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05392244 |
| Other study ID # |
NFEC-2022-076 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 30, 2022 |
| Est. completion date |
August 31, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Nanfang Hospital of Southern Medical University |
| Contact |
Shuai Chu |
| Phone |
18665000310 |
| Email |
shine9533[@]smu.edu.cn |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The etiology and precipitating factors of PNS remain unclear. Dysfunction of immunologic
function is a classic theory of the pathogenesis of PNS. This study was aimed at
investigating the characteristics of peripheral blood lymphocyte subsets and exploring its
value of predicting infection in children with primary nephrotic syndrome (PNS).
Description:
As a common type of nephrosis in children, primary nephrotic syndrome (PNS) is a clinical
syndrome characterized by a heavy proteinuria, hypoalbuminemia, edema, and hyperlipidemia,
caused by increased plasma protein permeability of the glomerular filtration membrane. To
date, the etiology and precipitating factors of PNS remain unclear. Dysfunction of
immunologic function is a classic theory of the pathogenesis of PNS, especially dysfunction
of lymphocytes and lymphocyte subsets.
Lymphocyte subsets level can reflect human cellular immune function, which performs different
biological functions, and coordinate with each other to maintain the body's immune function
homeostasis. At present, many studies have shown that abnormal cellular immune function is
closely related to the pathogenesis of PNS in children. Compared with children with PNS with
mild proteinuria, CD8+ T cells were significantly increased in children with large
proteinuria, and CD4+ T cells were reduced compared with healthy children and children with
stable phase. NK cells are also considered to be an indicator that can assess the prognosis
of children with PNS. Abnormal number or function of Regulatory T cells (Treg) may be
involved in the occurrence of PNS proteinuria, and the urine protein level of the rat model
can be relieved by the increase of Treg cells. Although studies have found abnormalities in
the lymphocyte subsets of children with PNS, these conclusions are not consistent, indicating
that the relationship between cellular immunity and the pathogenesis of children with PNS
remains to be studied.
Children with PNS are susceptible to various of infections. After the application of
glucocorticoids, children with PNS are more susceptible to infection, even if the infection
is not serious, which can lead to recurrence of PNS or affect the curative efficacy of
treatment. Studies have found that corticosteroid therapy affects the distribution of
lymphocyte subsets in children with PNS, and changes in the level of CD4+ T cells are related
to the occurrence and severity of infection in children with NS. The above studies all
indicate that lymphocyte subsets analysis has important research significance in the
occurrence and prevention of infections in children with PNS.
In this study, we observed the profiles of peripheral blood lymphocyte subsets in healthy
children and children with PNS, and explored the risk factor of infection in children with
PNS.
