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

Diabetes Mellitus Clinical Trial

Official title:

The Effect of a Probiotic on Hepatic Steatosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00068094
• Other study ID #: R21AT001305
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 5, 2003
• Last updated: August 16, 2006
• Start date: July 2005
• Est. completion date: February 2006

Study information

• Verified date: August 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Fatty Liver
• Hepatic Steatosis
• Liver Diseases

Intervention

Drug:
• Probiotic-containing powder

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation