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Completed

NCT Number: NCT01762748

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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Belo Horizonte, Minas Gerais, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saccharomyces boulardii

Drug

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

Primary outcomes

  1. Intestinal permeability

    Time frame: Change from intestinal permeability at two months

    Intestinal permeability test was conducted at the lactulose and mannitol excretion

Secondary outcomes

  1. Effect of Saccharomyces boulardii on laboratory parameters

    Time frame: Change from laboratory parameters in two months

  2. Number of participants with adverse effect

    Time frame: Adverse effect in two months

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 8, 2013
Registry last updated
Jan 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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