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Treatment of Nonalcoholic Fatty Liver Disease With Probiotics and Prebiotics

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Completed

Conditions

Nonalcoholic Fatty Liver Disease

Treatments

Other: Simple lifestyle advice
Drug: Lepicol probiotic & prebiotic formula

Study type

Interventional

Funder types

Other

Identifiers

NCT00870012
NAFLD-GUT#2

Details and patient eligibility

About

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).

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups, including a placebo group

Lepicol probiotic & prebiotic formula+simple lifestyle advice
Active Comparator group
Treatment:
Other: Simple lifestyle advice
Drug: Lepicol probiotic & prebiotic formula
Simple lifestyle advice alone
Placebo Comparator group
Treatment:
Other: Simple lifestyle advice

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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