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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020859

Enrollment

Registered

2016-02-05

Start date

2015-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus.

Interventions

two-month Royal Jelly (2 gm) treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: children with SLE

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Africa

Contacts

Public ContactKhaled Saad

Faculty of medicine, University of Assiut, Assiut 71516, Egypt. pediatrics

med@aun.edu.eg+20882368373

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026