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The Effect of a Probiotic on Hepatic Steatosis

This study has been terminated.
(The hypothesis that probiotics would reduce hepatic steatosis in humans was not supported)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00099723
First Posted: December 20, 2004
Last Update Posted: February 11, 2010
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:
VSL Pharmaceuticals
  Purpose
Non-alcoholic fatty liver disease (NAFLD) is an accumulation of fat and fibrous tissue in the liver. It is the most common cause of chronic liver disease in the United States. The exact cause of NAFLD is unknown, but it is more common among people with conditions such as adult-onset diabetes. NAFLD can strike people of all ages but most often affects adults between the ages of 40 and 60. Research indicates that overgrowth of gut bacteria can start a chain of biological processes that stress the liver, causing liver inflammation. Probiotics, living bacteria taken orally, may decrease the stress on the liver by reducing this bacterial overgrowth and/or strengthening the gut walls. Because probiotics are generally safe, inexpensive, and easy to tolerate they are an attractive treatment option for NAFLD.

Condition Intervention Phase
Fatty Liver Drug: VSL#3 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group 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 VSL Pharmaceuticals:

Primary Outcome Measures:
  • MRI
  • Liver biopsy
  • Blood work

Estimated Enrollment: 30
Study Start Date: October 2004
Estimated Study Completion Date: December 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult-onset diabetes
  • Liver biopsy in the previous 2 months with diagnosis of fatty liver and fibrosis stage F2-F3

Exclusion Criteria:

  • There are multiple exclusion criteria.
  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): NCT00099723


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
VSL Pharmaceuticals
Investigators
Principal Investigator: Steve Solga, MD Johns Hopkins University
  More Information

ClinicalTrials.gov Identifier: NCT00099723     History of Changes
Other Study ID Numbers: SS01305-01
R21AT001305-01 ( U.S. NIH Grant/Contract )
First Submitted: December 17, 2004
First Posted: December 20, 2004
Last Update Posted: February 11, 2010
Last Verified: December 2004

Keywords provided by VSL Pharmaceuticals:
Hepatic steatosis
adult-onset diabetes
Non-alcoholic fatty liver disease

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases