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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01411748
First Posted: August 8, 2011
Last Update Posted: August 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital
  Purpose
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.

Condition Intervention Phase
Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants Dietary Supplement: Reflor Drug: mikostatin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Primary Outcome Measures:
  • Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Effect of S. boulardii on sepsis [ Time Frame: 6 months ]

Estimated Enrollment: 140
Study Start Date: July 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S. boulardii
The patients in this group will be given 5 million unit/day S. boulardii until discharge.
Dietary Supplement: Reflor
5 million unit/day, orally, beginning on the second day of life, until discharge from hospital
Active Comparator: nystatin Drug: mikostatin
50000 unit/3 times a day, both for orally and by orogastric route

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Very low birth weight infants < 1500 gr

Exclusion Criteria:

  • Genetic anomalies
  • Not willing to participate
  • Allergy to S. boulardii components
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411748


Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology Recruiting
Ankara, Turkey, 06230
Contact: Gamze Demirel, MD    +905324540156    kgamze@hotmail.com   
Principal Investigator: Gamze Demirel, MD         
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

Publications:
Responsible Party: Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01411748     History of Changes
Other Study ID Numbers: demirel98
First Submitted: August 5, 2011
First Posted: August 8, 2011
Last Update Posted: August 8, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Nystatin
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action