The Effect of a Probiotic on Hepatic Steatosis

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00099723

Enrollment

Registered

2004-12-20

Start date

2004-10-31

Completion date

2005-12-31

Last updated

2010-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver

Keywords

Hepatic steatosis, adult-onset diabetes, Non-alcoholic fatty liver disease

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.

Interventions

DRUGVSL#3

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

45 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
MRI	—
Liver biopsy	—
Blood work	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026