Connective Tissue DiseasesNCT03494036
Effect of Synbiotic on Immune Response, Gut Permeability and Microbiota in Patient With Connective Tissue Disease
A study testing Synbiotic in people with Connective Tissue Diseases, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Connective Tissue Diseases
- What is being tested?
- Synbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2017to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients diagnosed with connective tissue disease
- has gastrointestinal symptoms (abdominal pain, diarrhea, constipation, or bloating)
- age between 18-60 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Connective Tissue Diseases
- Being tested
- Synbiotic, Placebo
- Keywords
- synbiotic, probiotic, lupus, connective tissue disease
- Medical subject headings
- Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticDietary supplement
capsule
PlaceboDietary supplement
capsule
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic | Experimental | 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 Receives: Dietary Supplement: Synbiotic |
| Placebo | Placebo comparator | Placebo capsule containing saccharum lactis. The dosage is once daily and it is given for 60 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FOXP3 regulatory T cell
change in the percentage of FOXP3 regulatory T cell
Measured: 2 months
Secondary outcomes (3)
IL-17
change in the serum IL-17 level
Measured: 2 months
zonulin
change in the serum zonulin level
Measured: 2 months
gut microbiota
change of the profile of gut microbiota
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start1 Oct 2017
- Primary completion31 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Connective Tissue DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alvinawidhani, Fakultas Kedokteran Universitas Indonesia
- Investigators
- alvina widhani, MD, Principal investigator, Faculty of Medicine University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494036
- Sponsor's protocol ID
- 804/UN2.F1/ETIK/2017
- Status last verified
- Mar 2019
- First submitted
- 31 Mar 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03494036
- Acronym / sponsor ID
- 804/UN2.F1/ETIK/2017
- Conditions
- Connective Tissue Diseases
- Keywords
- synbiotic, probiotic, lupus, connective tissue disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic | Experimental | Dietary Supplement: SynbioticSynbiotic 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 comparator | Dietary Supplement: PlaceboPlacebo capsule containing saccharum lactis. The dosage is once daily and it is given for 60 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients diagnosed with connective tissue disease
- has gastrointestinal symptoms (abdominal pain, diarrhea, constipation, or bloating)
- age between 18-60 years old
Key exclusion criteria (6 listed)
- 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\
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synbioticcapsule | Dietary supplement | Synbiotic |
| Placebocapsule | Dietary supplement | Placebo |
Primary outcome
FOXP3 regulatory T cell
Time frame: 2 months
change in the percentage of FOXP3 regulatory T cell
3 secondary outcomes
IL-17
Time frame: 2 months
zonulin
Time frame: 2 months
gut microbiota
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
alvina widhani, MD principal investigator
Faculty of Medicine University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic in people with Connective Tissue Diseases, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FOXP3 regulatory T cell (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.