ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
The Effect of Good Bacteria on Nonalcoholic Fatty Liver Disease in Diabetics

This study has been terminated.
Study NCT00068094.   Last updated on August 16, 2006.   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  The Effect of Good Bacteria on Nonalcoholic Fatty Liver Disease in Diabetics
Official Title  The Effect of a Probiotic on Hepatic Steatosis
Brief Summary

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.

Detailed Description

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.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Fatty Liver
Hepatic Steatosis
Diabetes Mellitus
Liver Diseases
Intervention  Drug: Probiotic-containing powder
MEDLINE PMIDs 12713883,   12540784
Links
Recruitment Information Fields
Recruitment Status  Terminated
Enrollment  30
Start Date  July 2005
Completion Date February 2006
Eligibility Criteria 

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
Gender Both
Ages 18 Years to 70 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00068094
Organization ID R21 AT001305
Secondary IDs ††
Study Sponsor  National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators ††
Investigators 
Principal Investigator:     Steve Solga, MD     Johns Hopkins University    
Information Provided By National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date August 2006
First Received Date  September 5, 2003
Last Updated Date August 16, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers