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The Effect of Good Bacteria on Nonalcoholic Fatty Liver Disease in Diabetics

Primary Purpose

Fatty Liver, Hepatic Steatosis, Diabetes Mellitus

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Probiotic-containing powder

About this trial

This is an interventional treatment trial for Fatty Liver focused on measuring Probiotics, Bacteria

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Nonalcoholic fatty liver disease Exclusion Criteria: 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

Sites / Locations

Johns Hopkins University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00068094

First Posted

September 5, 2003

Last Updated

August 16, 2006

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT00068094

Brief Title

The Effect of Good Bacteria on Nonalcoholic Fatty Liver Disease in Diabetics

Official Title

The Effect of a Probiotic on Hepatic Steatosis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2006

Overall Recruitment Status

Terminated

Study Start Date

July 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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.

Detailed Description

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the United States and is also common in diabetics; unfortunately, research on NAFLD has been limited. Safe, inexpensive, and well-tolerated treatments for NAFLD are needed. Recent studies indicate that probiotics help to improve fat breakdown in mice. This study will evaluate the efficacy of probiotic therapy to reduce fat accumulation in the livers of people with NAFLD and diabetes. Participants in this study will be randomly assigned to receive either a probiotic-containing mixture or placebo once daily for 6 months. Blood tests, and magnetic resonance spectroscopy will be used to assess participants at study start and at study completion.

6. Conditions and Keywords

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

Fatty Liver, Hepatic Steatosis, Diabetes Mellitus, Liver Diseases

Keywords

Probiotics, Bacteria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

30 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Probiotic-containing powder

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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 University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12713883

Citation

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.

Results Reference

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PubMed Identifier

12540784

Citation

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.

Results Reference

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The Effect of Good Bacteria on Nonalcoholic Fatty Liver Disease in Diabetics

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