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Probiotic Effect on Hepatic Steatosis



Probiotic Effect on Hepatic Steatosis

For Condition: Fatty Liver,Hepatic Steatosis
Status: Not yet recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: The purpose of this study is to evaluate the effect of a probiotic on hepatic steatosis. "Probiotics" are living bacteria given to improve health. "Hepatic Steatosis" is a condition of increased fat in the liver, and can lead to serious health problems in some persons.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - NAFLD (Non-alcoholic fatty liver disease) as diagnosed by liver biopsy; presumed diagnosis should also include: a. Elevated ASAT, ALT, or GGT; b. Negative Hep B & C serologies; c. Transferrin saturation <50%; d. Average daily alcohol intake of <2drinks/day. - Diagnosis of DM as determined by: a. Fasting plasma glucose >126 mg/dl or random plasma glucose of >200 mg/dl. Exclusion Criteria - Evidence of cirrhosis on liver biopsy; - Unable or unwilling to under go MR (magnetic resonance) procedures, i.e., metal fragments present, severe claustrophobia, over 350 lbs. - Patients requiring long-term antibiotic therapy for any reason; - Pregnant, planning to become pregnant, or nursing; - Unable or unwilling to provide informed consent; - Any cause of liver disease other than hepatic steatosis (e.g., hepatitis C, alcohol use).
Total Enrollment: 30

Location and Contact Information:

Overall Study Official:
AnnaDiehl,  Principal Investigator,  Johns Hopkins University

Johns Hopkins University
Baltimore,  Maryland,  21205
United States
Steve  Solga 410-502-7720


Additional Information:
Study ID Numbers:
  R21AT1305;  Diehl
Study Start Date: October 2003
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068094

Other Fatty Liver Studies:
1. Probiotic Effect on Hepatic Steatosis

2. Clinical Research Network in Non-alcoholic Steatohepatitis - Pediatric Trial

3. Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition

4. Treatment of Nonalcoholic Steatohepatitis with Pioglitazone

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