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Trial record 2 of 5 for:    ALVINA

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

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ClinicalTrials.gov Identifier: NCT03494036
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
alvinawidhani, Fakultas Kedokteran Universitas Indonesia

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.

Condition or disease Intervention/treatment Phase
Connective Tissue Diseases Dietary Supplement: Synbiotic Dietary Supplement: Placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Synbiotic
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
Dietary Supplement: Synbiotic
capsule
Placebo Comparator: Placebo
Placebo capsule containing saccharum lactis. The dosage is once daily and it is given for 60 days
Dietary Supplement: Placebo
capsule



Primary Outcome Measures :
  1. FOXP3 regulatory T cell [ Time Frame: 2 months ]
    change in the percentage of FOXP3 regulatory T cell


Secondary Outcome Measures :
  1. IL-17 [ Time Frame: 2 months ]
    change in the serum IL-17 level

  2. zonulin [ Time Frame: 2 months ]
    change in the serum zonulin level

  3. gut microbiota [ Time Frame: 2 months ]
    change of the profile of gut microbiota



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494036


Contacts
Contact: alvina widhani, MD +62213904546 alvina.widhani@gmail.com

Locations
Indonesia
Cipto Mangunkusumo Hospital Recruiting
Jakarta, Indonesia
Contact: alvina widhani, MD    +62213904546    alvina.widhani@gmail.com   
Principal Investigator: alvina widhani, MD         
Sponsors and Collaborators
Fakultas Kedokteran Universitas Indonesia
Investigators
Principal Investigator: alvina widhani, MD Faculty of Medicine University of Indonesia

Responsible Party: alvinawidhani, Principal Investigator, Fakultas Kedokteran Universitas Indonesia
ClinicalTrials.gov Identifier: NCT03494036     History of Changes
Other Study ID Numbers: 804/UN2.F1/ETIK/2017
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by alvinawidhani, Fakultas Kedokteran Universitas Indonesia:
synbiotic
probiotic
lupus
connective tissue disease

Additional relevant MeSH terms:
Connective Tissue Diseases