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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01762748

Enrollment

Registered

2013-01-08

Start date

2011-01-31

Completion date

2012-12-31

Last updated

2013-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

Keywords

Probiotic, liver, transplant, permeability

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.

Interventions

DRUGSaccharomyces boulardii

Oral capsule with 200 mg lyophilized S. boulardii-17 (about 4x108 cells), 6 mg sucrose and 2.4 mg magnesium stearate (Floratil®).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Intestinal permeability	Change from intestinal permeability at two months	Intestinal permeability test was conducted at the lactulose and mannitol excretion

Secondary

Measure	Time frame
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026