Back to resultsEffect of Saccharomyces Boulardii in Patients in the Waiting List for Liver Transplant
Primary Purpose
Liver Cirrhosis
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Saccharomyces boulardii
Sponsored by
About this trial
This is an interventional supportive care trial for Liver Cirrhosis focused on measuring Probiotic, liver, transplant, permeability
Eligibility Criteria
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
Sites / Locations
- Alfa Institute of Gastroenterology - Transplant Outpatient Clinic at Federal University of Minas Gerais
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
S. boulardii 200mg (Floratil®)
Arm Description
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).
Outcomes
Primary Outcome Measures
Intestinal permeability
Intestinal permeability test was conducted at the lactulose and mannitol excretion
Secondary Outcome Measures
Effect of Saccharomyces boulardii on laboratory parameters
Number of participants with adverse effect
Full Information
NCT ID
NCT01762748
First Posted
January 3, 2013
Last Updated
January 8, 2013
Sponsor
Federal University of Minas Gerais
1. Study Identification
Unique Protocol Identification Number
NCT01762748
Brief Title
Effect of Saccharomyces Boulardii in Patients in the Waiting List for Liver Transplant
Official Title
Effect of Saccharomyces Boulardii in Patients in the Waiting List for Liver Transplant
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of Saccharomyces boulardii in patients in the waiting list for liver transplant.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Probiotic, liver, transplant, permeability
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S. boulardii 200mg (Floratil®)
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Saccharomyces boulardii
Other Intervention Name(s)
Floratil
Intervention Description
Oral capsule with 200 mg lyophilized S. boulardii-17 (about 4x108 cells), 6 mg sucrose and 2.4 mg magnesium stearate (Floratil®).
Primary Outcome Measure Information:
Title
Intestinal permeability
Description
Intestinal permeability test was conducted at the lactulose and mannitol excretion
Time Frame
Change from intestinal permeability at two months
Secondary Outcome Measure Information:
Title
Effect of Saccharomyces boulardii on laboratory parameters
Time Frame
Change from laboratory parameters in two months
Title
Number of participants with adverse effect
Time Frame
Adverse effect in two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Isabel Correia, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Juliana Liboredo, PhD degree
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfa Institute of Gastroenterology - Transplant Outpatient Clinic at Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effect of Saccharomyces Boulardii in Patients in the Waiting List for Liver Transplant
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