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

Federal University of Minas Gerais18 enrolled

Overview

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

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Liver Cirrhosis

Interventions

Saccharomyces boulardiiDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Alfa Institute of Gastroenterology - Transplant Outpatient Clinic at Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Outcomes

Primary Outcomes

Intestinal permeability

Intestinal permeability test was conducted at the lactulose and mannitol excretion

Time frame: Change from intestinal permeability at two months

Secondary Outcomes

Effect of Saccharomyces boulardii on laboratory parameters

Time frame: Change from laboratory parameters in two months

Number of participants with adverse effect

Time frame: Adverse effect in two months

Data from ClinicalTrials.gov

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