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

• Sponsor: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Overall Status: Terminated
• CT.gov ID: NCT00068094
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 7.1
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fatty Liver; Hepatic Steatosis; Diabetes Mellitus; Liver Diseases	Drug: Probiotic-containing powder	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: The Effect of a Probiotic on Hepatic Steatosis
• Study Start Date: Jul 1, 2005
• Study Completion Date: Feb 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Steve Solga, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Review.

• ClinicalTrials.gov Identifier: NCT00068094
• Other Study ID Numbers: R21AT001305
• First Posted: Sep 9, 2003
• Last Update Posted: Aug 18, 2006
• Last Verified: Aug 1, 2006

• Keywords provided by , ,: Probiotics; Bacteria
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver

Study Results

No Results Posted as of Aug 18, 2006