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The Effect of Good Bacteria on Nonalcoholic Fatty Liver Disease in Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00068094
Recruitment Status : Terminated
First Posted : September 9, 2003
Last Update Posted : August 18, 2006
Information provided by:

September 5, 2003
September 9, 2003
August 18, 2006
July 2005
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Complete list of historical versions of study NCT00068094 on ClinicalTrials.gov Archive Site
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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 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Fatty Liver
  • Hepatic Steatosis
  • Diabetes Mellitus
  • Liver Diseases
Drug: Probiotic-containing powder
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
February 2006
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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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R21AT001305( U.S. NIH Grant/Contract )
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National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Steve Solga, MD Johns Hopkins University
National Center for Complementary and Integrative Health (NCCIH)
August 2006

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