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Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants

Primary Purpose

Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Reflor
mikostatin
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants

Eligibility Criteria

1 Day - 90 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Very low birth weight infants < 1500 gr

Exclusion Criteria:

  • Genetic anomalies
  • Not willing to participate
  • Allergy to S. boulardii components

Sites / Locations

  • Zekai Tahir Burak Maternity Teaching Hospital, Division of NeonatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

S. boulardii

nystatin

Arm Description

The patients in this group will be given 5 million unit/day S. boulardii until discharge.

Outcomes

Primary Outcome Measures

Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants

Secondary Outcome Measures

Effect of S. boulardii on sepsis

Full Information

First Posted
August 5, 2011
Last Updated
August 5, 2011
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01411748
Brief Title
Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Saccharomyces boulardii was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic S boulardii in reducing the candida colonization and infection in very low birth weight infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S. boulardii
Arm Type
Experimental
Arm Description
The patients in this group will be given 5 million unit/day S. boulardii until discharge.
Arm Title
nystatin
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Reflor
Intervention Description
5 million unit/day, orally, beginning on the second day of life, until discharge from hospital
Intervention Type
Drug
Intervention Name(s)
mikostatin
Intervention Description
50000 unit/3 times a day, both for orally and by orogastric route
Primary Outcome Measure Information:
Title
Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Effect of S. boulardii on sepsis
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Very low birth weight infants < 1500 gr Exclusion Criteria: Genetic anomalies Not willing to participate Allergy to S. boulardii components
Facility Information:
Facility Name
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gamze Demirel, MD
Phone
+905324540156
Email
kgamze@hotmail.com
First Name & Middle Initial & Last Name & Degree
Gamze Demirel, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17317426
Citation
Chapman RL. Prevention and treatment of Candida infections in neonates. Semin Perinatol. 2007 Feb;31(1):39-46. doi: 10.1053/j.semperi.2007.01.006.
Results Reference
background
PubMed Identifier
20706577
Citation
Murzyn A, Krasowska A, Stefanowicz P, Dziadkowiec D, Lukaszewicz M. Capric acid secreted by S. boulardii inhibits C. albicans filamentous growth, adhesion and biofilm formation. PLoS One. 2010 Aug 10;5(8):e12050. doi: 10.1371/journal.pone.0012050.
Results Reference
background

Learn more about this trial

Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants

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