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Effect of Yogurt on Minimal Hepatic Encephalopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00312078
Recruitment Status : Completed
First Posted : April 7, 2006
Last Update Posted : November 1, 2007
National Center for Research Resources (NCRR)
Information provided by:
Medical College of Wisconsin

Brief Summary:
The purpose of this study is to determine whether a special yogurt can improve performance on certain tests of intelligence and decrease liver inflammation in patients with cirrhosis.

Condition or disease Intervention/treatment Phase
Cirrhosis Minimal Hepatic Encephalopathy Dietary Supplement: Yogurt Supplementation Not Applicable

Detailed Description:

Introduction: Cirrhosis is one of the leading causes of death in the United States. Minimal hepatic encephalopathy (MHE) is a significant complication of cirrhosis, which is often not treated because of perceived subclinical nature of this condition and the adverse effects and expense of available medications such as lactulose or rifaximin. There is evidence that small intestinal bacterial overgrowth can contribute to the development of MHE and cirrhosis in murine and human studies. Probiotics are live bacteria that can modify the indigenous intestinal bacterial flora and have been recently used in the treatment of hepatic encephalopathy in patients with cirrhosis.

Our aim is to evaluate the effect of probiotic supplementation via yogurt on liver function and inflammatory markers of bacterial translocation and psychometric test performance in cirrhotic patients with MHE in a prospective pilot trial.

Methods: 30 patients with MHE 2:1 i.e. 20 will be randomized into supplementation with yogurt to be taken 6 ounces twice a day for 60 days and 10 patients will be followed up without yogurt supplementation. All patients will undergo liver function tests, basic metabolic panel, INR, venous ammonia, IL-6 and TNF-alpha at baseline, 30 days and at 60 days. All patients will also undergo psychometric testing with number connection test A, digit symbol test, block design and inhibitory control test at baseline and 60 days. Regular questioning about adherence to yogurt. Collection of yogurt tops as proof of yogurt consumption and review of intake diary will be done at 30 and 60 days from patients randomized to yogurt supplementation.

Importance: There has been only one human study on the modification of gut flora as a therapeutic tool for improvement of MHE in cirrhosis, however that study included alcoholic liver disease and comprised of Chinese patients, therefore etiologies of liver diseases studied were different from those predominant in the United States. Since MHE can adversely affect quality of life and overall prognosis, simple, targeted therapies are needed to treat it. We believe that our pilot study will help delineate human gut flora as a definite target for therapy of cirrhosis and MHE and pave the way for future large-scale studies on this subject.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Yogurt Supplementation on Psychometric Test Performance in Cirrhotic Patients With Minimal Hepatic Encephalopathy. A Prospective Pilot Trial.
Study Start Date : November 2005
Actual Study Completion Date : April 2007

Primary Outcome Measures :
  1. Reversal of minimal hepatic encephalopathy

Secondary Outcome Measures :
  1. Decrease in AST/ALT

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cirrhosis diagnosed on clinical grounds (within 3 months of enrollment)
  • MHE diagnosed by abnormalities in a psychometric battery (NCT-A,BDT,DST and ICT)

Exclusion criteria:

  • Current or recent (< 6 month) use of alcohol
  • Co-existing cause of liver dysfunction
  • Use of antibiotics within last 6 weeks
  • Infection or gastrointestinal hemorrhage within the last 6 weeks
  • Hepatocellular carcinoma
  • Psychoactive drug use, including interferon concurrently

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00312078

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United States, Wisconsin
GCRC Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
National Center for Research Resources (NCRR)
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Principal Investigator: Jasmohan S Bajaj, MD Medical College of Wisconsin
Layout table for additonal information Identifier: NCT00312078    
Other Study ID Numbers: GCRC protocol 810; HRRC 360-05
First Posted: April 7, 2006    Key Record Dates
Last Update Posted: November 1, 2007
Last Verified: October 2007
Keywords provided by Medical College of Wisconsin:
Minimal Hepatic Encephalopathy
Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases