Effect of Saccharomyces Boulardii in Patients in the Waiting List for Liver Transplant

The purpose of this study is to evaluate the effect of Saccharomyces boulardii in patients in the waiting list for liver transplant.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Drug: Saccharomyces boulardii

Detailed Description

Increased intestinal permeability are related to the major complications of liver cirrhosis. The administration of probiotics has been suggested to improve the barrier function of the mucosa and consequently avoid the complications of the disease. The objective of this study was to evaluate the effect of Saccharomyces boulardii in patients in the waiting list for liver transplant.

Eighteen patients were treated with Saccharomyces boulardii. Intestinal permeability (lactulose/mannitol ratio) and laboratory parameters were evaluated immediately before the beginning of treatment, after a thirty-day period of treatment with probiotic and at the end of the second study month (after a thirty-day period without treatment with probiotic). Twenty healthy volunteers were also submitted for the intestinal permeability test.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
      • Alfa Institute of Gastroenterology - Transplant Outpatient Clinic at Federal University of Minas Gerais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients in the waiting list for liver transplant with viral, alcoholic or cryptogenic cirrhosis

Exclusion Criteria:

• patients younger than 18 years or older than 65 years.
• patients with renal failure, congestive heart failure, nephrotic syndrome, diabetes and thyroid diseases that interfered with absorption, flux of water and solutes and intestinal motility, in order to avoid interference with the intestinal permeability tests

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: S. boulardii 200mg (Floratil®); The patients received S. boulardii every 8h during 30 days as an oral capsule formulation which contained 200 mg lyophilized S. boulardii-17 (Floratil®). The patients enrolled in the study were evaluated immediately before the beginning of treatment, after a thirty-day period of treatment with probiotic and at the end of the second study month (after a thirty-day period without treatment with probiotic).

Drug: Saccharomyces boulardii; Oral capsule with 200 mg lyophilized S. boulardii-17 (about 4x108 cells), 6 mg sucrose and 2.4 mg magnesium stearate (Floratil®).; Other Names: Floratil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal permeability	Intestinal permeability test was conducted at the lactulose and mannitol excretion	Change from intestinal permeability at two months

Secondary Outcome Measures

Outcome Measure	Time Frame
Effect of Saccharomyces boulardii on laboratory parameters	Change from laboratory parameters in two months
Number of participants with adverse effect	Adverse effect in two months

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Study Chair: Maria Isabel Correia, PhD, Federal University of Minas Gerais; Principal Investigator: Juliana Liboredo, PhD degree, Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 3, 2013
• First Submitted That Met QC Criteria: January 7, 2013
• First Posted (Estimate): January 8, 2013

Study Record Updates

• Last Update Posted (Estimate): January 9, 2013
• Last Update Submitted That Met QC Criteria: January 8, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: transplant; Probiotic; liver; permeability
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ETIC 0609.0.203.000-09