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

Sponsor

Federal University of Minas Gerais (Other)

Overall Status

Completed

CT.gov ID

NCT01762748

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis	Drug: Saccharomyces boulardii	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Floratil

Arm

Intervention/Treatment

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 Names:

Floratil

Outcome Measures

Primary Outcome Measures

Intestinal permeability [Change from intestinal permeability at two months]
Intestinal permeability test was conducted at the lactulose and mannitol excretion

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alfa Institute of Gastroenterology - Transplant Outpatient Clinic at Federal University of Minas Gerais	Belo Horizonte	Minas Gerais	Brazil

Sponsors and Collaborators

Federal University of Minas Gerais

Investigators

Study Chair: Maria Isabel Correia, PhD, Federal University of Minas Gerais
Principal Investigator: Juliana Liboredo, PhD degree, Federal University of Minas Gerais