| Trial ID: | L0684 |
| Source ID: | NCT00870012
|
| Associated Drug: |
Lepicol probiotic
|
| Title: |
Treatment of Nonalcoholic Fatty Liver Disease With Probiotics and Prebiotics
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Fatty Liver Disease
|
| Interventions: |
Drug: Lepicol probiotic & prebiotic formula;Other: Simple lifestyle advice
|
| Outcome Measures: |
The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24.The proportion of patients with normal ALT at week 24 will be determined. Normal ALT is defined according to Prati's cutoffs (=30 IU/l in men and =19 IU/l in women).;The proportion of patients with impaired fasting glucose, diabetes, insulin resistance (estimated by the homeostasis model), hypertension, dyslipidemia and metabolic syndrome will be determined both at baseline and during each visit.;The changes in visceral fat will be determined by magnetic resonance imaging at the same session both at baseline and month 12.;The changes in liver fibrosis will be determined by transient elastography by Fibroscan both at baseline and month 12.;The percentage of total sequences of individual microbes will be calculated. In particular, the proportion of Firmicutes and Bacteroidetes will be compared between the two treatment arms.
|
| Sponsor/Collaborators: |
Chinese University of Hong Kong
|
| Gender: |
All
|
| Age: |
18 Years70 Years
|
| Phases: |
Not applicable
|
| Enrollment: |
20
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
|
| Start Date: |
25/03/2009
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
19 February 2015
|
| Locations: |
China
|
| URL: |
http://clinicaltrials.gov/show/NCT00870012
|
