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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00068094
Other study ID # R21AT001305
Secondary ID
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
Est. primary completion date
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


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

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