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The Effect of a Probiotic on Hepatic Steatosis

Primary Purpose

Fatty Liver

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VSL#3

About this trial

This is an interventional treatment trial for Fatty Liver focused on measuring Hepatic steatosis, adult-onset diabetes, Non-alcoholic fatty liver disease

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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 exclusion criteria.

Sites / Locations

Johns Hopkins Hospital

Outcomes

Primary Outcome Measures

MRI

Liver biopsy

Blood work

Secondary Outcome Measures

Full Information

NCT ID

NCT00099723

First Posted

December 17, 2004

Last Updated

February 10, 2010

Sponsor

VSL Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00099723

Brief Title

The Effect of a Probiotic on Hepatic Steatosis

Official Title

The Effect of a Probiotic on Hepatic Steatosis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2004

Overall Recruitment Status

Terminated

Why Stopped

The hypothesis that probiotics would reduce hepatic steatosis in humans was not supported

Study Start Date

October 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2005 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

VSL Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatty Liver

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

VSL#3

Primary Outcome Measure Information:

Title

MRI

Title

Liver biopsy

Title

Blood work

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steve Solga, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of a Probiotic on Hepatic Steatosis

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