Effect of Synbiotic on Immune Response, Gut Permeability and Microbiota in Patient With Connective Tissue Disease

Connective Tissue Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03494036
• Other study ID #: 804/UN2.F1/ETIK/2017
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: March 2019
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients diagnosed with connective tissue disease

• has gastrointestinal symptoms (abdominal pain, diarrhea, constipation, or bloating)

• age between 18-60 years old

Exclusion Criteria:

• pregnant or breastfeeding

• acute infection

• on antibiotic treatment

• taking yoghurt or probiotic supplementation in the last 3 weeks before recruitment

• taking corticosteroid more than 20 mg prednison a day or equal\

• refuse to join the study

Related Conditions & MeSH terms

• Connective Tissue Diseases

Intervention

Dietary Supplement:
• Synbiotic
capsule
• Placebo
capsule

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FOXP3 regulatory T cell	change in the percentage of FOXP3 regulatory T cell	2 months
Secondary	IL-17	change in the serum IL-17 level	2 months
Secondary	zonulin	change in the serum zonulin level	2 months
Secondary	gut microbiota	change of the profile of gut microbiota	2 months