Probiotic Lactobacillus GG (LGG) in Patients With Minimal Hepatic Encephalopathy

Completed · Phase 1 · Has a placebo group

Conditions studied: Minimal Hepatic Encephalopathy

In brief

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 action of LGG.

Key facts

Study ID

NCT00992290

Run by

Virginia Commonwealth University

People needed

37

Starts

2009-10-01

Expected to finish

2013-03-01

Last updated by the study team

2014-01-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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