Effect of Saccharomyces Boulardii in Patients in the Waiting List for Liver Transplant
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Effect of Saccharomyces Boulardii in Patients in the Waiting List for Liver Transplant|
- Intestinal permeability [ Time Frame: Change from intestinal permeability at two months ] [ Designated as safety issue: No ]Intestinal permeability test was conducted at the lactulose and mannitol excretion
- Effect of Saccharomyces boulardii on laboratory parameters [ Time Frame: Change from laboratory parameters in two months ] [ Designated as safety issue: No ]
- Number of participants with adverse effect [ Time Frame: Adverse effect in two months ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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).
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762748
|Alfa Institute of Gastroenterology - Transplant Outpatient Clinic at Federal University of Minas Gerais|
|Belo Horizonte, Minas Gerais, Brazil|
|Study Chair:||Maria Isabel Correia, PhD||Federal University of Minas Gerais|
|Principal Investigator:||Juliana Liboredo, PhD degree||Federal University of Minas Gerais|