| Trial ID: | L0503 |
| Source ID: | IRCT20100524004010N23
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| Associated Drug: |
Bacillus coagulans
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| Title: |
The effects of synbiotic supplement containing Bacillus coagulans and inulin on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
non alcoholic fatty liver disease. <br>K75.8;Other spec
|
| Interventions: |
Intervention 1: Intervention group: 2 synbiotic capsule containing Bacillus coagulans(0.1) g and inulin(0.9 g) per day for 3 months. Intervention 2: Control group: 2 placebo capsule containing 1gram maltodextrin per day for 3 months.
|
| Outcome Measures: |
LDL-C. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits.;Total cholestrol. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits.;HDL-C. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits.;TG. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits.;FBS. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits.;Serum insulin. Timepoint: Begining and end of intervention. Method of measurement: Radioimmunoassay.;AST. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits.;ALT. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits.;HOMA. Timepoint: Begining and end of intervention. Method of measurement: Calculation.;TNF-a. Timepoint: Begining and end of intervention. Method of measurement: Elisa.;Steatosis. Timepoint: Begining and end of intervention. Method of measurement: ultrasonography.;Fibrosis. Timepoint: Begining and end of intervention. Method of measurement: fibroscan.SFA. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day.;MUFA. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day.;PUFA. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day.;Carbohydrate intake. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day.;Protein intake. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day.;Fat intake. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day.
|
| Sponsor/Collaborators: |
Shahid Beheshti University of Medical Sciences
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| Gender: |
All
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| Age: |
18 yearsno limit
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| Phases: |
Not applicable
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| Enrollment: |
50
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomly assigned to receive synbiotic or placebo, Blinding description: Randomly assigned to interv
|
| Start Date: |
18/04/2018
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| Completion Date: |
--
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| Results First Posted: |
--
|
| Last Update Posted: |
21 May 2018
|
| Locations: |
Iran (Islamic Republic of)
|
| URL: |
http://en.irct.ir/trial/28722
|
