Cirrhosis Clinical Trial
Official title:
Effect of Yogurt Supplementation on Psychometric Test Performance in Cirrhotic Patients With Minimal Hepatic Encephalopathy. A Prospective Pilot Trial.
Verified date | October 2007 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 24 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | GCRC Medical College of Wisconsin | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin | National Center for Research Resources (NCRR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reversal of minimal hepatic encephalopathy | |||
Secondary | Decrease in AST/ALT |
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