Treatment of Nonalcoholic Fatty Liver Disease With Probiotics and Prebiotics

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT00870012
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	Phase
Nonalcoholic Fatty Liver Disease	Drug: Lepicol probiotic & prebiotic formula; Other: Simple lifestyle advice	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. [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). [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. [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. [12 months]

4. The changes in liver fibrosis will be determined by transient elastography by Fibroscan both at baseline and month 12. [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. [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

• Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Hui AY, Wong VW, Chan HL, Liew CT, Chan JL, Chan FK, Sung JJ. Histological progression of non-alcoholic fatty liver disease in Chinese patients. Aliment Pharmacol Ther. 2005 Feb 15;21(4):407-13.
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• Targher G, Bertolini L, Rodella S, Tessari R, Zenari L, Lippi G, Arcaro G. Nonalcoholic fatty liver disease is independently associated with an increased incidence of cardiovascular events in type 2 diabetic patients. Diabetes Care. 2007 Aug;30(8):2119-21. Epub 2007 May 22.
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• Wong VW, Hui AY, Tsang SW, Chan JL, Tse AM, Chan KF, So WY, Cheng AY, Ng WF, Wong GL, Sung JJ, Chan HL. Metabolic and adipokine profile of Chinese patients with nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2006 Sep;4(9):1154-61. Epub 2006 Aug 14.

• Responsible Party: Henry LY Chan, Professor, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT00870012
• Other Study ID Numbers: NAFLD-GUT#2
• First Posted: Mar 26, 2009
• Last Update Posted: Feb 24, 2014
• Last Verified: Feb 1, 2014

• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Feb 24, 2014