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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762748
• Other study ID #: ETIC 0609.0.203.000-09
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2013
• Last updated: January 8, 2013
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of Saccharomyces boulardii in patients in the waiting list for liver transplant.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

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®).

Locations

Country	Name	City	State
Brazil	Alfa Institute of Gastroenterology - Transplant Outpatient Clinic at Federal University of Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal permeability	Intestinal permeability test was conducted at the lactulose and mannitol excretion	Change from intestinal permeability at two months	No
Secondary	Effect of Saccharomyces boulardii on laboratory parameters		Change from laboratory parameters in two months	No
Secondary	Number of participants with adverse effect		Adverse effect in two months	Yes