Probiotic Lactobacillus GG (LGG) in Patients With Minimal Hepatic Encephalopathy
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 6, 2009 | ||||
| Last Updated Date | February 13, 2013 | ||||
| Start Date ICMJE | October 2009 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Safety of LGG [ Time Frame: 3 years ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Tolerability of LGG defined as adherence and adverse effects (as prescribed by the FDA) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00992290 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Probiotic Lactobacillus GG (LGG) in Patients With Minimal Hepatic Encephalopathy | ||||
| Official Title ICMJE | Probiotic LGG in Patients With Minimal Hepatic Encephalopathy | ||||
| Brief Summary | This research proposes to find whether the probiotic lactobacillus GG can help patients with minimal hepatic encephalopathy get better on psychometric tests. The investigators believe that this probiotic will improve performance on specialized tests, quality of life and are safe in patients with liver cirrhosis. |
||||
| 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 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. Specific aim 3: To determine the effect of LGG on metabolic biomarkers and cytokines in stool, urine and blood using nuclear magnetic resonance spectroscopy in minimal hepatic encephalopathy. Specific aim 4: To determine the effect of LGG on psychometric function in patients with minimal hepatic encephalopathy. The specific aim and sub-aims will be tested in 40 patients with non-alcoholic cirrhosis and MHE: 20 randomized to LGG and 20 randomized to placebo to be taken BID for 8 weeks with detailed psychometric, metabolic, anthropometric and bacteriologic evaluation. Results generated from this study will form the basis for a RO1 proposal to develop the use of probiotics as a biologically-based alternative treatment with long-term outcomes of prognosis, development of overt encephalopathy and prevention of traffic accidents in patients with MHE. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
||||
| Condition ICMJE | Minimal Hepatic Encephalopathy | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | March 2013 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00992290 | ||||
| Other Study ID Numbers ICMJE | HM12123, 1U01AT004428-01A1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Virginia Commonwealth University | ||||
| Study Sponsor ICMJE | Virginia Commonwealth University | ||||
| Collaborators ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Virginia Commonwealth University | ||||
| Verification Date | February 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||