Treatment of Nonalcoholic Fatty Liver Disease With Probiotics and Prebiotics

Not Applicable

Completed

• Conditions: Nonalcoholic Fatty Liver Disease
• Interventions: Other: Simple lifestyle advice; Drug: Lepicol probiotic & prebiotic formula

• Registration Number: NCT00870012
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-25
• Study First Posted: 2009-03-26
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-20
• Last Update Posted: 2014-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simple lifestyle advice alone	Simple lifestyle advice	-
Lepicol probiotic & prebiotic formula+simple lifestyle advice	Lepicol probiotic & prebiotic formula	-
Lepicol probiotic & prebiotic formula+simple lifestyle advice	Simple lifestyle advice	-

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24.	24 weeks

Secondary Outcome Measures

Name	Time	Method
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).	24 weeks
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.	24 weeks
The changes in visceral fat will be determined by magnetic resonance imaging at the same session both at baseline and month 12.	12 months
The changes in liver fibrosis will be determined by transient elastography by Fibroscan both at baseline and month 12.	12 months
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.	12 months

Trial Locations

Locations (1)

Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital; 🇨🇳 Hong Kong SAR, China