Effect of Synbiotic on Immune Response, Gut Permeability and Microbiota in Patient With Connective Tissue Disease
Effect of Synbiotic Supplementation on Interleukin 17 (IL-17) Level, Regulatory T-cells, Gut Permeability and Microbiota in Patient With Connective Tissue Disease
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 31, 2018
CompletedFirst Posted
Study publicly available on registry
April 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedMarch 12, 2019
March 1, 2019
10 months
March 31, 2018
March 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FOXP3 regulatory T cell
change in the percentage of FOXP3 regulatory T cell
2 months
Secondary Outcomes (3)
IL-17
2 months
zonulin
2 months
gut microbiota
2 months
Study Arms (2)
Synbiotic
EXPERIMENTALSynbiotic 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
PLACEBO COMPARATORPlacebo capsule containing saccharum lactis. The dosage is once daily and it is given for 60 days
Interventions
Eligibility Criteria
You may qualify if:
- patients diagnosed with connective tissue disease
- has gastrointestinal symptoms (abdominal pain, diarrhea, constipation, or bloating)
- age between 18-60 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cipto Mangunkusumo Hospital
Jakarta, Indonesia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
alvina widhani, MD
Faculty of Medicine University of Indonesia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 31, 2018
First Posted
April 11, 2018
Study Start
October 1, 2017
Primary Completion
July 31, 2018
Study Completion
August 31, 2018
Last Updated
March 12, 2019
Record last verified: 2019-03