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

NCT01686698 | Completed Phase 4

• 1 other identifier: IIBSP-VSL-2012-124
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis; Cognitive Dysfunction

Keywords

cirrhosis, VSL#3, cognitive function, falls, quality of life

Outcome Measures

Primary Outcomes (1)

• To assess the effect of VSL#3 (Original De Simone formulation) on cognitive function in patients with cirrhosis

  3 months

Study Arms (2)

VSL#3 (Original De Simone formulation)

ACTIVE COMPARATOR

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)

Placebo

PLACEBO COMPARATOR

Placebo sachets, 1 sachet every 12 hours during 3 months (n=20).

Other: Placebo

Interventions

VSL#3 (Original De Simone formulation) DIETARY_SUPPLEMENT

VSL#3 (Original De Simone formulation) is a probiotic mixture of 8 proprietary strains, namely Streptococcus thermophilus, bifidobacteria and lactobacilli.

VSL#3 (Original De Simone formulation)

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Fibrosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• German Soriano, PhD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 18, 2012
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2016
• Last Updated: May 19, 2016

Record last verified: 2016-05

Locations

ES (1)