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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020859
Receipt No. R000024073
Scientific Title Effects of Royal Jelly Supplementation on Regulatory T Cells and Lymphocytes Apoptosis in Children with Systemic Lupus Erythematosus
Date of disclosure of the study information 2016/02/05
Last modified on 2017/02/16

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Basic information
Public title Effects of Royal Jelly Supplementation on Regulatory T Cells and Lymphocytes Apoptosis in Children with Systemic Lupus Erythematosus
Acronym Royal Jelly Supplementation in SLE
Scientific Title Effects of Royal Jelly Supplementation on Regulatory T Cells and Lymphocytes Apoptosis in Children with Systemic Lupus Erythematosus
Scientific Title:Acronym 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
1st name
Middle name
Last name Khaled Saad
Organization Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Division name pediatrics
Zip code
Address Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
TEL +20882413683
Email med@aun.edu.eg

Public contact
Name of contact person
1st name
Middle name
Last name Khaled Saad
Organization Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Division name pediatrics
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 08 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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