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

This study has been terminated.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00068094
First received: September 5, 2003
Last updated: August 16, 2006
Last verified: August 2006
  Purpose

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.


Condition Intervention Phase
Fatty Liver
Hepatic Steatosis
Diabetes Mellitus
Liver Diseases
Drug: Probiotic-containing powder
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of a Probiotic on Hepatic Steatosis

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 30
Study Start Date: July 2005
Estimated Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068094

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Investigators
Principal Investigator: Steve Solga, MD Johns Hopkins University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00068094     History of Changes
Other Study ID Numbers: R21 AT001305
Study First Received: September 5, 2003
Last Updated: August 16, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Probiotics
Bacteria

Additional relevant MeSH terms:
Diabetes Mellitus
Liver Diseases
Fatty Liver
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014