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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juliana Costa Liboredo, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01762748
First received: January 3, 2013
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Liver Cirrhosis
Drug: Saccharomyces boulardii
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect of Saccharomyces Boulardii in Patients in the Waiting List for Liver Transplant

Resource links provided by NLM:


Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • Intestinal permeability [ Time Frame: Change from intestinal permeability at two months ] [ Designated as safety issue: No ]
    Intestinal permeability test was conducted at the lactulose and mannitol excretion


Secondary Outcome Measures:
  • Effect of Saccharomyces boulardii on laboratory parameters [ Time Frame: Change from laboratory parameters in two months ] [ Designated as safety issue: No ]
  • Number of participants with adverse effect [ Time Frame: Adverse effect in two months ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Floratil

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762748

Locations
Brazil
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
  More Information

No publications provided

Responsible Party: Juliana Costa Liboredo, Fellow PhD degree, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01762748     History of Changes
Other Study ID Numbers: ETIC 0609.0.203.000-09
Study First Received: January 3, 2013
Last Updated: January 8, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Minas Gerais:
Probiotic
liver
transplant
permeability

Additional relevant MeSH terms:
Liver Cirrhosis
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on November 27, 2014