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

Phase 2TerminatedNCT00068094

National Center for Complementary and Integrative Health (NCCIH)30 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fatty Liver Hepatic Steatosis Diabetes Mellitus Liver Diseases

Interventions

Probiotic-containing powderDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States

Data from ClinicalTrials.gov

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