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

Phase 1

Terminated

• Conditions: Fatty Liver; Hepatic Steatosis; Diabetes Mellitus; Liver Diseases

• Registration Number: NCT00068094
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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 Timeline

• Study First Submitted: 2003-09-05
• Study First Submitted QC: 2003-09-08
• Study First Posted: 2003-09-09
• Study Start: 2005-07
• Study Completion: 2006-02
• Status Verified: 2006-08
• Last Update Submitted: 2006-08-16
• Last Update Posted: 2006-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States