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

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

This study has been terminated.

Study NCT00068094. Last updated on August 16, 2006. Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

The Effect of a Probiotic on Hepatic Steatosis

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 Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Fatty Liver
Hepatic Steatosis
Diabetes Mellitus
Liver Diseases

Intervention ^†

Drug: Probiotic-containing powder

MEDLINE PMIDs

12713883, 12540784

Links

Recruitment Information Fields

Recruitment Status ^†

Terminated

Enrollment ^†

Start Date ^†

July 2005

Completion Date

February 2006

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00068094

Organization ID

R21 AT001305

Secondary IDs ^††

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^††

Investigators ^†

Principal Investigator:

Steve Solga, MD

Johns Hopkins University

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

August 2006

First Received Date ^†

September 5, 2003

Last Updated Date

August 16, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.