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
|Condition or disease||Intervention/treatment||Phase|
|Fatty Liver Hepatic Steatosis Diabetes Mellitus Liver Diseases||Drug: Probiotic-containing powder||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of a Probiotic on Hepatic Steatosis|
|Study Start Date :||July 2005|
|Study Completion Date :||February 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068094
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Steve Solga, MD||Johns Hopkins University|