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

NCT01762748 | Completed Phase 2

• 1 other identifier: ETIC 0609.0.203.000-09
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Cirrhosis

Keywords

Probiotic; liver; transplant; permeability

Outcome Measures

Primary Outcomes (1)

• Intestinal permeability

  Intestinal permeability test was conducted at the lactulose and mannitol excretion

  Change from intestinal permeability at two months

Secondary Outcomes (2)

• 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

Study Arms (1)

S. boulardii 200mg (Floratil®)

EXPERIMENTAL

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

Interventions

Saccharomyces boulardii DRUG

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

Also known as: Floratil

S. boulardii 200mg (Floratil®)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients in the waiting list for liver transplant with viral, alcoholic or cryptogenic cirrhosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Alfa Institute of Gastroenterology - Transplant Outpatient Clinic at Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Isabel Correia, PhD

  Federal University of Minas Gerais

  STUDY CHAIR

• Juliana Liboredo, PhD degree

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow PhD degree

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 8, 2013
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 9, 2013

Record last verified: 2013-01

Locations

BR (1)