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The Effect of Good Bacteria on Nonalcoholic Fatty Liver Disease in Diabetics
This study has been terminated.
Study NCT00068094   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: September 5, 2003   Last Updated: August 16, 2006   History of Changes

September 5, 2003
August 16, 2006
July 2005
 
 
 
Complete list of historical versions of study NCT00068094 on ClinicalTrials.gov Archive Site
 
 
 
The Effect of Good Bacteria on Nonalcoholic Fatty Liver Disease in Diabetics
The Effect of a Probiotic on Hepatic Steatosis

The purpose of this study is to determine whether probiotics, bacteria that may improve liver health, can effectively treat a chronic condition in diabetics that increases fat in the liver.

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the United States and is also common in diabetics; unfortunately, research on NAFLD has been limited. Safe, inexpensive, and well-tolerated treatments for NAFLD are needed. Recent studies indicate that probiotics help to improve fat breakdown in mice. This study will evaluate the efficacy of probiotic therapy to reduce fat accumulation in the livers of people with NAFLD and diabetes.

Participants in this study will be randomly assigned to receive either a probiotic-containing mixture or placebo once daily for 6 months. Blood tests, and magnetic resonance spectroscopy will be used to assess participants at study start and at study completion.

Phase I, Phase II
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
  • Fatty Liver
  • Hepatic Steatosis
  • Diabetes Mellitus
  • Liver Diseases
Drug: Probiotic-containing powder
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
30
February 2006
 

Inclusion Criteria:

  • Nonalcoholic fatty liver disease

Exclusion Criteria:

  • Any cause of liver disease other than hepatic steatosis
  • Diabetes
  • Known or suspected cirrhosis
  • Inability or unwillingness to undergo magnetic resonance procedures
  • Requirement of long-term antibiotic therapy
  • Pregnancy, breast-feeding, or plans to become pregnant
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00068094
 
R21 AT001305
National Center for Complementary and Alternative Medicine (NCCAM)
 
Principal Investigator: Steve Solga, MD Johns Hopkins University
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP