Effect of VSL#3 (Original De Simone Formulation) on Cognitive Function, Risk of Falls and Quality of Life in Patients With Cirrhosis
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|ClinicalTrials.gov Identifier: NCT01686698|
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : May 19, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis Cognitive Dysfunction||Dietary Supplement: VSL#3 (Original De Simone formulation) Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Study of the Effect of VSL#3 (Original De Simone Formulation) on Cognitive Function, Risk of Falls and Quality of Life in Patients With Cirrhosis|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2016|
Active Comparator: VSL#3 (Original De Simone formulation)
VSL#3 (Original De Simone formulation) sachets containing 450 x 109 bacteria, 1 sachet every 12 hours during 3 months (n=20).
Dietary Supplement: VSL#3 (Original De Simone formulation)
VSL#3 (Original De Simone formulation) 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).
Placebo will be formulated as identical in appearance and administered according to the same schedule as the active agent. Placebo contains maltose and silicon dioxide as inactive agent.
- To assess the effect of VSL#3 (Original De Simone formulation) on cognitive function in patients with cirrhosis [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686698
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|
|Principal Investigator:||German Soriano, PhD||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|