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

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ClinicalTrials.gov Identifier: NCT01762748
Recruitment Status : Completed
First Posted : January 8, 2013
Last Update Posted : January 9, 2013
Sponsor:
Information provided by (Responsible Party):
Juliana Costa Liboredo, Federal University of Minas Gerais

January 3, 2013
January 8, 2013
January 9, 2013
January 2011
December 2012   (Final data collection date for primary outcome measure)
Intestinal permeability [ Time Frame: Change from intestinal permeability at two months ]
Intestinal permeability test was conducted at the lactulose and mannitol excretion
Same as current
Complete list of historical versions of study NCT01762748 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Saccharomyces Boulardii in Patients in the Waiting List for Liver Transplant
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Liver Cirrhosis
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 Name: Floratil
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).

Intervention: Drug: Saccharomyces boulardii
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
Same as current
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01762748
ETIC 0609.0.203.000-09
No
Not Provided
Not Provided
Juliana Costa Liboredo, Federal University of Minas Gerais
Federal University of Minas Gerais
Not Provided
Study Chair: Maria Isabel Correia, PhD Federal University of Minas Gerais
Principal Investigator: Juliana Liboredo, PhD degree Federal University of Minas Gerais
Federal University of Minas Gerais
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP