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OpenTrials
Completed

NCT Number: NCT00870012

Treatment of Nonalcoholic Fatty Liver Disease With Probiotics and Prebiotics

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).

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Key information

Conditions

Nonalcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital

Hong Kong SAR, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lepicol probiotic & prebiotic formula

Drug

NAFLD patients treated with Lepicol probiotic and prebiotic formula for 24 weeks.

simple lifestyle advice

Other

NAFLD patients treated with lifestyle advice.

Primary outcomes

  1. The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24.

    Time frame: 24 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 26, 2009
Registry last updated
Feb 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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