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

Primary Purpose

Connective Tissue Diseases

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Synbiotic
Placebo
Sponsored by
Fakultas Kedokteran Universitas Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Connective Tissue Diseases focused on measuring synbiotic, probiotic, lupus, connective tissue disease

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cipto Mangunkusumo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Synbiotic

Placebo

Arm Description

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

Placebo capsule containing saccharum lactis. The dosage is once daily and it is given for 60 days

Outcomes

Primary Outcome Measures

FOXP3 regulatory T cell
change in the percentage of FOXP3 regulatory T cell

Secondary Outcome Measures

IL-17
change in the serum IL-17 level
zonulin
change in the serum zonulin level
gut microbiota
change of the profile of gut microbiota

Full Information

First Posted
March 31, 2018
Last Updated
March 10, 2019
Sponsor
Fakultas Kedokteran Universitas Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT03494036
Brief Title
Effect of Synbiotic on Immune Response, Gut Permeability and Microbiota in Patient With Connective Tissue Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fakultas Kedokteran Universitas Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Connective Tissue Diseases
Keywords
synbiotic, probiotic, lupus, connective tissue disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Synbiotic
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule containing saccharum lactis. The dosage is once daily and it is given for 60 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Synbiotic
Intervention Description
capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
capsule
Primary Outcome Measure Information:
Title
FOXP3 regulatory T cell
Description
change in the percentage of FOXP3 regulatory T cell
Time Frame
2 months
Secondary Outcome Measure Information:
Title
IL-17
Description
change in the serum IL-17 level
Time Frame
2 months
Title
zonulin
Description
change in the serum zonulin level
Time Frame
2 months
Title
gut microbiota
Description
change of the profile of gut microbiota
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
alvina widhani, MD
Organizational Affiliation
Faculty of Medicine University of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta
Country
Indonesia

12. IPD Sharing Statement

Learn more about this trial

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

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