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TerminatedNCT00099723Updated Feb 11, 2010

The Effect of a Probiotic on Hepatic Steatosis

A Phase 1 interventional study of VSL#3 in Fatty Liver, sponsored by VSL Pharmaceuticals. Terminated at 1 site in United States. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-02-11.

Sponsored by VSL Pharmaceuticals · Phase 1, Interventional, and Treatment

Why this study was terminated
The hypothesis that probiotics would reduce hepatic steatosis in humans was not supported
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fatty Liver

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Keywords

  • Hepatic steatosis
  • adult-onset diabetes
  • Non-alcoholic fatty liver disease
03

In context

Fatty Liver

1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 1,003 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

VSL Pharmaceuticals is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • There are multiple exclusion criteria.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
30 participants (estimated)

Interventions

  • DrugVSL#3
06

What researchers measure

Primary outcomes

  1. MRI

  2. Liver biopsy

  3. Blood work

07

Study locations

1 site
  • Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00099723
Lead sponsor
VSL Pharmaceuticals
First posted
Dec 20, 2004
Start date
Oct 2004
Completion
Dec 2005 (estimated)
Last update
Feb 11, 2010

Study contacts

Steve Solga, MD
principal investigator · Johns Hopkins University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2004. You cannot join it, but the record below documents what was studied.

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