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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Probiotic LGG in Patients With Minimal Hepatic Encephalopathy

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 action of LGG.

Detailed Summary:

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 result in poor quality of life, impaired cognition and difficulty in driving motor vehicles with a high traffic accident risk. MHE is estimated to affect one half of the 5.5 million cirrhotics in the U.S. Despite these negative outcomes, there is no consensus on treatment of MHE. Currently available therapies for MHE act on intestinal flora but are limited by adverse effects (i.e. lactulose-induced diarrhea), which negatively impact adherence. Probiotic bacterial supplements, which also act on intestinal flora, are an emerging therapy for MHE. Our group has performed a pilot, randomized trial which demonstrated a significantly higher rate of MHE reversal with excellent adherence in patients randomized to probiotic yogurt compared to no therapy. This proposal intends to define Lactobacillus GG (LGG) as a biologically-based alternative therapy for MHE with special focus on metabolic and stool bacteriologic changes.

The hypothesis of this Phase I proposal is: LGG will be safe and efficacious for the treatment of minimal hepatic encephalopathy compared to placebo in a randomized, double-blind trial.

This will be carried out with four specific aims:

Specific aim 1: To define the safety and tolerability of LGG in patients with minimal hepatic encephalopathy against placebo in a Phase I randomized controlled trial.

Specific aim 2: To define the effect of LGG on intestinal microflora composition in cirrhotics with minimal hepatic encephalopathy using 16s stool DNA sequencing in a randomized, placebo-controlled trial.

  • Quality of life measured by sickness impact profile [ Time Frame: 3 years ]
  • Bacteriology measured in the stool flora by specialized non-culture techniques [ Time Frame: 3 years ]
  • Metabonomics and psychometric testing using a standard psychometric battery [ Time Frame: 3 years ]


    • Original Secondary Outcome: Same as current

    Information By: Virginia Commonwealth University

    Dates:
    Date Received: October 6, 2009
    Date Started: October 2009
    Date Completion:
    Last Updated: January 6, 2014
    Last Verified: January 2014