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Effect of VSL#3 (Original De Simone Formulation) on Cognitive Function, Risk of Falls and Quality of Life in Patients With Cirrhosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01686698
First Posted: September 18, 2012
Last Update Posted: May 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  Purpose

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 Intervention Phase
Cirrhosis Cognitive Dysfunction Dietary Supplement: VSL#3 (Original De Simone formulation) Other: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • To assess the effect of VSL#3 (Original De Simone formulation) on cognitive function in patients with cirrhosis [ Time Frame: 3 months ]

Enrollment: 40
Study Start Date: March 2013
Study Completion Date: March 2016
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Other: Placebo
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.

  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients with cirrhosis visited at Hospital de la Santa Creu i Sant Pau. Cirrhosis will be diagnosed by clinical, analytical and ultrasonographic findings or by liver biopsy.

Exclusion Criteria:

  • Hospitalization in the previous month due to decompensation of cirrhosis. Hepatocellular carcinoma or any other malignancy.
  • Active alcohol intake (in the previous 3 months).
  • Current overt acute or chronic hepatic encephalopathy.
  • Clinically significant cognitive impairment according to Short Portable Mental Status Questionnaire (SPMSQ) > 5 points.
  • Neurological disease.
  • Inability to perform psychometric tests.
  • Marked symptomatic comorbidities (cardiac, pulmonary, renal, untreated active depression).
  • Life expectancy less than 6 months.
  • Treatment with non-absorbable disaccharides.
  • Treatment with antiviral drugs.
  • Antibiotic treatment (norfloxacin).
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: German Soriano, PhD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  More Information

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01686698     History of Changes
Other Study ID Numbers: IIBSP-VSL-2012-124
First Submitted: September 13, 2012
First Posted: September 18, 2012
Last Update Posted: May 19, 2016
Last Verified: May 2016

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
cirrhosis, VSL#3, cognitive function, falls, quality of life

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Cognitive Dysfunction
Pathologic Processes
Liver Diseases
Digestive System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders