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Trial record 2 of 3 for:    16447287 [PUBMED-IDS]

Treatment of Nonalcoholic Fatty Liver Disease With Probiotics and Prebiotics

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ClinicalTrials.gov Identifier: NCT00870012
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : February 24, 2014
Sponsor:
Information provided by (Responsible Party):
Henry LY Chan, Chinese University of Hong Kong

Brief Summary:
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).

Condition or disease Intervention/treatment
Nonalcoholic Fatty Liver Disease Drug: Lepicol probiotic & prebiotic formula Other: Simple lifestyle advice

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Study Start Date : February 2009
Primary Completion Date : January 2012
Study Completion Date : January 2012


Arm Intervention/treatment
Active Comparator: Lepicol probiotic & prebiotic formula+simple lifestyle advice 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.
Placebo Comparator: Simple lifestyle advice alone Other: Simple lifestyle advice
NAFLD patients treated with lifestyle advice.



Primary Outcome Measures :
  1. The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. The changes in liver fibrosis will be determined by transient elastography by Fibroscan both at baseline and month 12. [ Time Frame: 12 months ]
  5. 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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00870012


Locations
China
Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Henry LY Chan, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00870012     History of Changes
Other Study ID Numbers: NAFLD-GUT#2
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: February 24, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases