NCT00099723

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2004

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

February 11, 2010

Status Verified

December 1, 2004

First QC Date

December 17, 2004

Last Update Submit

February 10, 2010

Conditions

Fatty Liver

Keywords

Hepatic steatosisadult-onset diabetesNon-alcoholic fatty liver disease

Outcome Measures

Primary Outcomes (3)

  • MRI

  • Liver biopsy

  • Blood work

Interventions

VSL#3DRUG

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Fatty LiverDiabetes Mellitus, Type 2Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Steve Solga, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 17, 2004

First Posted

December 20, 2004

Study Start

October 1, 2004

Study Completion

December 1, 2005

Last Updated

February 11, 2010

Record last verified: 2004-12

Locations

US(1)