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Effects of Royal Jelly Supplementation on Regulatory T Cells and Lymphocytes Apoptosis in Children with Systemic Lupus Erythematosus

Not Applicable
Conditions
Systemic Lupus Erythematosus.
Registration Number
JPRN-UMIN000020859
Lead Sponsor
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

Patients and controls with known diabetes, subjects who had received a 'recent' vaccination, were excluded from the study. Any patient had recent infection or received any immunosuppressive medications e.g. steroids, etc. during one month prior to enrollment were also excluded.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
In the current study, we found that the children with SLE (in both before and after treatment groups) had significantly lower levels of CD4 Treg and Foxp3 expression in CD4+CD25+High versus normal control group. Also, the levels of CD4 and Foxp3 expression were negatively correlated with disease activity as detected by SLEDAI index.
Secondary Outcome Measures
NameTimeMethod
After RJ treatment, we found a significant increase in CD4 Treg and in the expression of Foxp3 in CD4+CD25+High versus baseline values. In parallel to this significant laboratory value, we found a significant improvement in the disease activity as detected by SLEDAI index after 2 months of RJ treatment which was correlated with the significant changes in CD4 Treg and Foxp3 expression. CD4 T lymphocytes count was increased after RJ treatment versus baseline value. Also the CD4/CD8 ratio is showing significant improvement after RJ treatment in SLE group. As regards to the effect of RJ treatment on lymphocytes apoptosis in our study, we found that the apoptotic CD4 T lymphocytes showed significant reduction to about its quarter of the baseline values before treatment to a values about normal as normal control group. Again in correlation with the previous CD8 T lymphocytes count, the changes in apoptotic CD8 T lymphocytes were not significant between any of the 3 groups.
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