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


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

This study is not yet open for patient recruitment.

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

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.

Condition	Treatment or Intervention	Phase
Fatty Liver Hepatic Steatosis Diabetes Mellitus Liver Diseases	Drug: Probiotic-containing pills	Phase I Phase II

MedlinePlus related topics: Diabetes; Liver Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: The Effect of a Probiotic on Hepatic Steatosis

Further Study Details:

Expected Total Enrollment: 30

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 probiotic-containing pills or placebo once daily for 6 months. Biopsies, blood tests, and magnetic resonance spectroscopy will be used to assess participants at study start and at study completion.

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

Nonalcoholic fatty liver disease
Diabetes

Exclusion Criteria:

Any cause of liver disease other than hepatic steatosis
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

Location Information

Steve Solga, MD 410-614-9765 solga@jhmi.edu

Maryland
Johns Hopkins University, Baltimore, Maryland, 21205, United States

Steve Solga, MD 410-614-9765 solga@jhmi.edu
Anna Mae Diehl, MD, Principal Investigator

Study chairs or principal investigators

Anna Mae Diehl, MD, Principal Investigator, Duke University

More Information

Publications

Solga SF, Diehl AM. Non-alcoholic fatty liver disease: lumen-liver interactions and possible role for probiotics. J Hepatol. 2003 May;38(5):681-7. No abstract available.

Li Z, Yang S, Lin H, Huang J, Watkins PA, Moser AB, Desimone C, Song XY, Diehl AM. Probiotics and antibodies to TNF inhibit inflammatory activity and improve nonalcoholic fatty liver disease. Hepatology. 2003 Feb;37(2):343-50.

Study ID Numbers: 1-R21-AT001305
Record last reviewed: September 2004
Record first received: September 5, 2003
ClinicalTrials.gov Identifier: NCT00068094
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-27

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