Diabetes Mellitus, Fatty Liver, Hepatic Steatosis, Liver Diseases
Conditions
Keywords
Probiotics, Bacteria
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.
Interventions
DRUGProbiotic-containing powder
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed