Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00312078
Status:
COMPLETED
Last Update Posted:
2007-11-01
First Post:
2006-04-05
Brief Title:
Effect of Yogurt on Minimal Hepatic Encephalopathy
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Effect of Yogurt Supplementation on Psychometric Test Performance in Cirrhotic Patients With Minimal Hepatic Encephalopathy A Prospective Pilot Trial
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 21 ie 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
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 21 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None