Status:
COMPLETED
Probiotic Lactobacillus GG (LGG) in Patients With Minimal Hepatic Encephalopathy
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Minimal Hepatic Encephalopathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This research proposes to find whether the probiotic lactobacillus GG is safe and well tolerated in patients with minimal hepatic encephalopathy. We also want to get insight into the mechanisms of act...
Detailed Description
Development of complementary and alternative medicine approaches to liver disease is a priority area at NCCAM. Minimal hepatic encephalopathy (MHE) is a significant complication of cirrhosis which can...
Eligibility Criteria
Inclusion
- Age: 18-65 years
- Histological evidence of cirrhosis
- Maintenance of cirrhosis treatment and stability for 6 months
- Mini-mental state exam score \> 25
- Presence of MHE on psychometric testing
Exclusion
- Rx for MHE or OHE
- Antibiotics within 6 weeks
- Yogurt consumption within 2 weeks
- Neutrophil count \< 500
- Inflammatory bowel disease
- History of pancreatitis
- Hepato-cellular carcinoma
- Recent (6 weeks) gastrointestinal bleed
- Recent (6 months) alcohol intake
- Psychoactive medications (including interferon/antipsychotics)
- Liver transplant
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00992290
Start Date
October 1 2009
End Date
March 1 2013
Last Update
January 7 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298