The Effect of a Probiotic on Hepatic Steatosis | NCT00099723

Studies
The Effect of a Probiotic on Hepatic Steatosis

NCT00099723

Sponsor

VSL Pharmaceuticals

Status

Terminated

Last Update Posted

Feb 11, 2010Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Fatty Liver

Interventions

VSL#3

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R21AT001305-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2004

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Not provided

Start Date

Oct 2004

Primary Completion Date

Not provided

Completion Date

Dec 2005Estimated

First Submitted Date

Dec 17, 2004

First Submission Date that Met QC Criteria

Dec 17, 2004

First Posted Date

Dec 20, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2010

Last Update Posted Date

Feb 11, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
VSL#3	Drug

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steve Solga, MD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins Hospital		Baltimore	Maryland	21287	United States

Condition Browse Module

MeSH Terms

ID	Term
D005234	Fatty Liver
D003924	Diabetes Mellitus, Type 2
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
MRI
Liver biopsy
Blood work