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

Phase 2

Completed

• Conditions: Liver Cirrhosis
• Interventions: Drug: Saccharomyces boulardii

• Registration Number: NCT01762748
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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

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 Timeline

• Study Start: 2011-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-08
• Last Update Submitted: 2013-01-08
• Last Update Posted: 2013-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S. boulardii 200mg (Floratil®)	Saccharomyces boulardii	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).

Primary Outcome Measures

Name	Time	Method
Intestinal permeability	Change from intestinal permeability at two months	Intestinal permeability test was conducted at the lactulose and mannitol excretion

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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