Effect of Synbiotic on Immune Response, Gut Permeability and Microbiota in Patient With Connective Tissue Disease
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|ClinicalTrials.gov Identifier: NCT03494036|
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : March 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Connective Tissue Diseases||Dietary Supplement: Synbiotic Dietary Supplement: Placebo||Not Applicable|
Study showed gut microbiota has a role in the pathogenesis of autoimmune diseases. Gut microbiota which can increase gut permeability affect the antigen presentation to the immune system. Synbiotic supplementation is expected to improve immune system, gut permeability, and gut microbiota in patients with connective tissue disease.
The subjects who fulfill inclusion criteria, willing to participate and sign informed consent will be randomized into two groups: the group receiving synbiotic containing probiotic (Lactobacillus helveticus R0052 60%, Bifidobacterium infantis R0033 20%, dan Bifidobacterium bifidum R0071 20%) and 80 mg fructooligosaccharide (group I, n=23) and the group receiving placebo (group II, n=23). Both groups receive intervention for two months. Patients continue to receive their immunosuppressive drugs (corticosteroids, hydroxychloroquine, mycophenolate mofetil, azathioprine, or cyclosporine).
Percentage of FOXP3 Regulatory T-cells, serum IL-17, zonulin, high sensitivity C-reactive protein, and gut microbiota are evaluated at the beginning and at the end of the study. FOXP3 regulatory T-cell is evaluated by flowcytometry. Serum IL-17 and zonulin are measured by ELISA. Gut microbiota is evaluated using 16s ribosomal RNA gene next generation sequencing. The DNA from the stool is isolated by DNA stool mini kit (QIAamp).
The results are presented in mean ± standard deviation, median (IQR 25-75%) and n (%). The Kolmogorov-Smirnov test is used to determine the normality of the data, assuming the normality of the data is fulfilled if p> 0.05. Bivariate analysis uses paired T test if the data has normal distribution. If the distribution is not normal, Wilcoxon test will be used. Differences are said to be significant when the value of p <0.05.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Synbiotic Supplementation on Interleukin 17 (IL-17) Level, Regulatory T-cells, Gut Permeability and Microbiota in Patient With Connective Tissue Disease|
|Actual Study Start Date :||October 1, 2017|
|Actual Primary Completion Date :||July 31, 2018|
|Actual Study Completion Date :||August 31, 2018|
Synbiotic capsule containing 3x1.000.000.000 Colony Forming Units probiotics (Lactobacillus helveticus R0052 60%, Bifidobacterium infantis R0033 20%, dan Bifidobacterium bifidum R0071 20%) and fructooligosaccharide 80 mg. The dosage is once daily and it is given for 60 days
Dietary Supplement: Synbiotic
Placebo Comparator: Placebo
Placebo capsule containing saccharum lactis. The dosage is once daily and it is given for 60 days
Dietary Supplement: Placebo
- FOXP3 regulatory T cell [ Time Frame: 2 months ]change in the percentage of FOXP3 regulatory T cell
- IL-17 [ Time Frame: 2 months ]change in the serum IL-17 level
- zonulin [ Time Frame: 2 months ]change in the serum zonulin level
- gut microbiota [ Time Frame: 2 months ]change of the profile of gut microbiota
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494036
|Cipto Mangunkusumo Hospital|
|Principal Investigator:||alvina widhani, MD||Faculty of Medicine University of Indonesia|