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

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

Detailed Description
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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.

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

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Drug: Saccharomyces boulardii


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S. boulardii 200mg (Floratil®)<br>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<br>* Oral capsule with 200 mg lyophilized S. boulardii-17 (about 4x108 cells), 6 mg sucrose and 2.4 mg magnesium stearate (Floratil®).<br>* Other names: Floratil;|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic, liver, transplant, permeability