The Effect of Probiotics (VSL) on Portal Hypertension

NCT01032941 | Completed Phase 1

• 1 other identifier: VSL3PHTNUoA
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will address the hypothesis that portal hypertension is mediated in part by bacterial or endotoxin translocation and the production of inflammatory mediators (tumor necrosis factor-α (TNFα), etc.). The investigators hypothesize that food supplementation with the probiotic product VSL#3 in patients with Child Pugh B/C cirrhosis will have a beneficial effect on in portal pressure (as measured by the HVPG) by reducing inflammatory mediators and improving systemic and splanchnic hemodynamics.

Conditions

Portal Hypertension

Keywords

Portal Hypertension; Portal Pressure Measurement; VSL3; Cirrhosis; End Stage Liver Disease; Probiotics

Outcome Measures

Primary Outcomes (1)

• Reduction in portal pressure

  12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients in this group will be given placebo 2 packets BID for 8 weeks.

Drug: Probiotic

VSL#3

EXPERIMENTAL

Patients in this group will be given 2 packets of VSL#3 BID for 8 weeks.

Drug: Probiotic

Interventions

Probiotic DRUG

Patients in this group will be given the probiotic VSL#3 2 packets BID for a total of 8 weeks.

Also known as: VSL#3

Placebo; VSL#3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80
• Cirrhosis
• Childs-Pugh Class B/C

You may not qualify if:

• Bacterial infection
• Grade 3-4 hepatic encephalopathy
• GI bleeding in the past 2 weeks
• Hepatocellular carcinoma beyond the Milan criteria
• Transjugular intrahepatic portosystemic shunt (TIPS), surgical shunt
• Portal vein thrombosis
• Antibiotics in the past 2 weeks
• Myocardial infarction, stroke or life-threatening arrhythmia within the last 6 months
• Active alcohol or illicit drug use
• Failure to consent to the study

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

MeSH Terms

Conditions

Hypertension, Portal; Fibrosis; End Stage Liver Disease

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Puneeta Tandon, MD, FRCPC, MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Vince Bain, MD, FRCPC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 16, 2009
• Study Start: December 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 20, 2012

Record last verified: 2012-01

Locations

CA (1)