UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Royal Jelly Supplementation on Regulatory T Cells and Lymphocytes Apoptosis in Children with Systemic Lupus Erythematosus
Title of the study (Brief title)	Royal Jelly Supplementation in SLE
Region	Africa

Condition
Condition	Systemic Lupus Erythematosus.
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To the best of our knowledge, no previous studies on the immunomodulatory effect of royal jelly administration on SLE patients in humans. Our aim was to study the effect of royal jelly administration on the disease course of pediatric SLE with some immunological markers (the CD4 Tregs and CD8 Tregs) and lymphocytes apoptosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	two-month Royal Jelly (2 gm) treatment
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	8 years-old <=
Age-upper limit	17 years-old >=
Gender	Male and Female
Key inclusion criteria	children with SLE
Key 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.
Target sample size	30

Research contact person
Name of lead principal investigator	Khaled Saad
Organization	Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Division name	pediatrics
Address	Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
TEL	+20882413683
Email	med@aun.edu.eg

Public contact
Name of contact person	Khaled Saad
Organization	Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Division name	pediatrics
Address	Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
TEL	+20882368373
Homepage URL
Email	med@aun.edu.eg

Sponsor
Institute	Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Institute
Department

Funding Source
Organization	Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 05 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 08 Month 01 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2016 Year 01 Month 15 Day
Date of closure to data entry	2016 Year 01 Month 21 Day
Date trial data considered complete	2016 Year 01 Month 31 Day
Date analysis concluded	2016 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 03 Day
Last modified on	2017 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024073