Effect of VSL#3 on Cognitive Function, Risk of Falls and Quality of Life in Patients With Cirrhosis
Probiotics, due to their ability to modulate intestinal flora, intestinal permeability and immune response, could decrease bacterial translocation and improve immune system alterations in cirrhosis. This could lead not only to improvement in liver function and to prevent bacterial infections and other complications but also to improve CD and to avoid its consequences falls, HRQoL deterioration).
Recently, the investigators have observed that VSL#3 administration to rats with experimental cirrhosis decreases bacterial translocation, inflammatory response and ascites formation, without changes in intestinal flora. This suggests an improvement in intestinal barrier that deserves further investigation.
VSL#3, through decreasing intestinal bacterial translocation and immune system modulation, could improve cognitive function and prevent the consequences of CD, including falls and HRQoL deterioration, in patients with cirrhosis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Study of the Effect of VSL#3 on Cognitive Function, Risk of Falls and Quality of Life in Patients With Cirrhosis|
- To assess the effect of VSL#3 on cognitive function in patients with cirrhosis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2013|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: VSL#3
VSL#3 sachets containing 450 x 109 bacteria, 1 sachet every 12 hours during 3 months (n=20).
VSL#3 is a probiotic mixture of 8 proprietary strains, namely Streptococcus thermophilus, bifidobacteria and lactobacilli.
Placebo Comparator: Placebo
Placebo sachets, 1 sachet every 12 hours during 3 months (n=20).
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|Hospital de la Santa Creu i Sant Pau||Recruiting|
|Barcelona, Spain, 08025|
|Contact: German Soriano, MD firstname.lastname@example.org|
|Principal Investigator: German Soriano, MD|