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Treatment of Nonalcoholic Fatty Liver Disease With Probiotics and Prebiotics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00870012
First received: March 25, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

March 25, 2009
March 25, 2009
February 2009
December 2011   (final data collection date for primary outcome measure)
The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The changes in visceral fat will be determined by magnetic resonance imaging at the same session both at baseline and month 12. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The changes in liver fibrosis will be determined by transient elastography by Fibroscan both at baseline and month 12. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Nonalcoholic Fatty Liver Disease With Probiotics and Prebiotics
Not Provided

The investigators' aim is to determine whether probiotic and prebiotic treatment plus lifestyle advice is more effective in reducing hepatic fat content than lifestyle advice alone in patients with Nonalcoholic Fatty Liver Disease (NAFLD).
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Nonalcoholic Fatty Liver Disease
  • Drug: Lepicol probiotic & prebiotic formula
    NAFLD patients treated with Lepicol probiotic and prebiotic formula for 24 weeks.
  • Other: Simple lifestyle advice
    NAFLD patients treated with lifestyle advice.
  • Active Comparator: Lepicol probiotic & prebiotic formula+simple lifestyle advice
    Interventions:
    • Drug: Lepicol probiotic & prebiotic formula
    • Other: Simple lifestyle advice
  • Placebo Comparator: Simple lifestyle advice alone
    Intervention: Other: Simple lifestyle advice

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 to 70 years
  • Fatty liver identified by imaging studies including ultrasound, computer tomography or magnetic resonance imaging
  • Elevated alanine aminotransferase (ALT) according to Prati's criteria (>30 IU/l in men and >19 IU/l in women)18
  • Written informed consent obtained

Exclusion Criteria:

  • Positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-nuclear antibody titer above 1/160
  • Alcohol consumption above 30 g per week in men or 20 g per week in women
  • ALT above 10 times the upper limit of normal
  • Liver decompensation, as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 109/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices
  • Use of systemic corticosteroids and methotrexate in the last 6 months
  • Evidence of hepatocellular carcinoma
  • Terminal illness or cancer, unless in complete remission for more than 5 years
Both
18 Years to 70 Years
No
Contact: Vincent WS Wong, MD 26323387 wongv@cuhk.edu.hk
Contact: Angel ML Chim 26324205 angelchim@cuhk.edu.hk
China
 
NCT00870012
NAFLD-GUT#2
No
Professor Vincent WS Wong, The Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Not Provided
Chinese University of Hong Kong
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP