Trials / Terminated
TerminatedNCT00068094
The Effect of Good Bacteria on Nonalcoholic Fatty Liver Disease in Diabetics
The Effect of a Probiotic on Hepatic Steatosis
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (planned)
- Sponsor
- National Center for Complementary and Integrative Health (NCCIH) · NIH
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Probiotic-containing powder |
Timeline
- Start date
- 2005-07-01
- Completion
- 2006-02-01
- First posted
- 2003-09-09
- Last updated
- 2006-08-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00068094. Inclusion in this directory is not an endorsement.