Treatment of Nonalcoholic Fatty Liver Disease With Probiotics and Prebiotics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Henry LY Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00870012
First received: March 25, 2009
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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 Intervention
Nonalcoholic Fatty Liver Disease
Drug: Lepicol probiotic & prebiotic formula
Other: Simple lifestyle advice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: February 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Additional 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
Study First Received: March 25, 2009
Last Updated: February 20, 2014
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2014