We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00068094
First Posted: September 9, 2003
Last Update Posted: August 18, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  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 Intervention Phase
Fatty Liver Hepatic Steatosis Diabetes Mellitus Liver Diseases Drug: Probiotic-containing powder Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of a Probiotic on Hepatic Steatosis

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Estimated Enrollment: 30
Study Start Date: July 2005
Estimated Study Completion Date: February 2006
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068094


Locations
United States, Maryland
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00068094     History of Changes
Other Study ID Numbers: R21AT001305 ( U.S. NIH Grant/Contract )
First Submitted: September 5, 2003
First Posted: September 9, 2003
Last Update Posted: August 18, 2006
Last Verified: August 2006

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Probiotics
Bacteria

Additional relevant MeSH terms:
Diabetes Mellitus
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases