NCT00068094

Brief Summary

The purpose of this study is to determine whether probiotics, bacteria that may improve liver health, can effectively treat a chronic condition in diabetics that increases fat in the liver.

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 Jul 2005

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

September 5, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2003

Completed
1.8 years until next milestone

Study Start

First participant enrolled

July 1, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

September 5, 2003

Last Update Submit

August 16, 2006

Conditions

Fatty LiverHepatic SteatosisDiabetes MellitusLiver Diseases

Keywords

ProbioticsBacteria

Interventions

Probiotic-containing powderDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nonalcoholic fatty liver disease

You may not qualify if:

  • Any cause of liver disease other than hepatic steatosis
  • Diabetes
  • Known or suspected cirrhosis
  • Inability or unwillingness to undergo magnetic resonance procedures
  • Requirement of long-term antibiotic therapy
  • Pregnancy, breast-feeding, or plans to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

  • Solga SF, Diehl AM. Non-alcoholic fatty liver disease: lumen-liver interactions and possible role for probiotics. J Hepatol. 2003 May;38(5):681-7. doi: 10.1016/s0168-8278(03)00097-7. No abstract available.

    PMID: 12713883BACKGROUND

  • Li Z, Yang S, Lin H, Huang J, Watkins PA, Moser AB, Desimone C, Song XY, Diehl AM. Probiotics and antibodies to TNF inhibit inflammatory activity and improve nonalcoholic fatty liver disease. Hepatology. 2003 Feb;37(2):343-50. doi: 10.1053/jhep.2003.50048.

    PMID: 12540784BACKGROUND

MeSH Terms

Conditions

Fatty LiverDiabetes MellitusLiver Diseases

Condition Hierarchy (Ancestors)

Digestive System DiseasesGlucose 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
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 5, 2003

First Posted

September 9, 2003

Study Start

July 1, 2005

Study Completion

February 1, 2006

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

US(1)