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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03494036 |
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Date of registration:
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31/03/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Synbiotic on Immune Response, Gut Permeability and Microbiota in Patient With Connective Tissue Disease
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Scientific title:
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Effect of Synbiotic Supplementation on Interleukin 17 (IL-17) Level, Regulatory T-cells, Gut Permeability and Microbiota in Patient With Connective Tissue Disease |
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Date of first enrolment:
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October 1, 2017 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03494036 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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alvina widhani, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Medicine University of Indonesia |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Connective Tissue Diseases
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: Synbiotic
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Primary Outcome(s)
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FOXP3 regulatory T cell
[Time Frame: 2 months]
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Secondary Outcome(s)
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gut microbiota
[Time Frame: 2 months]
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zonulin
[Time Frame: 2 months]
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IL-17
[Time Frame: 2 months]
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Secondary ID(s)
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804/UN2.F1/ETIK/2017
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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