Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH) Identifier:
First received: September 5, 2003
Last updated: August 16, 2006
Last verified: August 2006

September 5, 2003
August 16, 2006
July 2005
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Complete list of historical versions of study NCT00068094 on 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 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
18 Years to 70 Years
Contact information is only displayed when the study is recruiting subjects
United States
R21 AT001305
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National Center for Complementary and Integrative Health (NCCIH)
Not Provided
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