Effect of Yogurt on Minimal Hepatic Encephalopathy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00312078
First received: April 5, 2006
Last updated: October 31, 2007
Last verified: October 2007
  Purpose

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 Intervention
Cirrhosis
Minimal Hepatic Encephalopathy
Dietary Supplement: Yogurt Supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Reversal of minimal hepatic encephalopathy

Secondary Outcome Measures:
  • Decrease in AST/ALT

Estimated Enrollment: 30
Study Start Date: November 2005
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   24 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00312078

Locations
United States, Wisconsin
GCRC Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Jasmohan S Bajaj, MD Medical College of Wisconsin
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00312078     History of Changes
Other Study ID Numbers: GCRC protocol 810; HRRC 360-05
Study First Received: April 5, 2006
Last Updated: October 31, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Minimal Hepatic Encephalopathy
Cirrhosis

Additional relevant MeSH terms:
Hepatic Encephalopathy
Liver Cirrhosis
Fibrosis
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on July 29, 2014