Clinical Trials Logo

Clinical Trial Summary

This is a double blind randomized placebo controlled trial to determine the effect of synbiotic to FOXP3 regulatory T cells, IL-17, gut permeability and gut microbiota in patients with connective tissue disease. Synbiotic can increase FOXP3 regulatory T cells, decrease IL-17 and improve gut permeability and gut microbiota in patients with connective tissue disease.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03494036
Study type Interventional
Source Fakultas Kedokteran Universitas Indonesia
Contact
Status Completed
Phase N/A
Start date October 1, 2017
Completion date August 31, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT04169100 - Novel Form of Acquired Long QT Syndrome Phase 4
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Active, not recruiting NCT03688191 - Study of Sirolimus in CTD-TP in China Phase 4
Completed NCT00004357 - Absorption of Corticosteroids in Children With Juvenile Dermatomyositis Phase 2
Recruiting NCT04918524 - The Clinical Features and Pregnancy Outcomes of CTD Patients
Recruiting NCT04993885 - Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies Phase 2
Not yet recruiting NCT05998759 - Telitacicept for the Treatment of Connective Tissue Disease-associated Thrombocytopenia Phase 2
Recruiting NCT05065814 - Connective Tissue Diseases and Vitamin D Deficiency N/A
Completed NCT03929120 - Allogeneic Bone Marrow Mesenchymal Stem Cells for Patients With Interstitial Lung Disease (ILD) & Connective Tissue Disorders (CTD) Phase 1
Completed NCT00001330 - Study of Silicone-Associated Connective Tissue Diseases N/A
Not yet recruiting NCT05980728 - Connective Tissue Disease Patients With Pulmonary Hypertension
Not yet recruiting NCT04582292 - Laryngeal Manifestations of Connective Tissue Diseases
Completed NCT06458803 - Efficacy and Safety of Eltrombopag for Refractory Thrombocytopenia Associated With Connective Tissue Disease
Recruiting NCT03214263 - Identification of New Biomarkers to Promote Personalized Treatment of Patients With Inflammatory Rheumatic Diseases
Completed NCT04171362 - The Effect of Connective Tissue Massage in Patients With Migraine N/A
Completed NCT02392130 - A Clinical Trial to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin Phase 1
Completed NCT01656278 - An MRI-guided Treatment Strategy to Prevent Disease Progression in Patients With Rheumatoid Arthritis N/A
Recruiting NCT04915482 - TPO-RAs Combined With Anti-CD20 Antibody in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies Phase 2/Phase 3
Recruiting NCT05505409 - Efficacy and Safety of Pirfenidone in CTD-ILD Phase 4
Recruiting NCT02768259 - Prevalence of Pulmonary Arterial Hypertension in Patients With Connective Tissue Diseases in Egyptian Patients N/A