Cirrhosis Clinical Trial
Official title:
Effect of Yogurt Supplementation on Psychometric Test Performance in Cirrhotic Patients With Minimal Hepatic Encephalopathy. A Prospective Pilot Trial.
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.
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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