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:
Information provided by:
VSL Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00099723
First received: December 17, 2004
Last updated: February 10, 2010
Last verified: December 2004
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00099723     History of Changes
Other Study ID Numbers: SS01305-01, R21 AT-01305-01
Study First Received: December 17, 2004
Last Updated: February 10, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 31, 2014