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 because the information has not been verified recently.
Verified July 2011 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier:
NCT01411748
First received: August 5, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effect of S. boulardii on sepsis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   up to 90 Days
Genders Eligible for Study:   Both
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
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: 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
Study First Received: August 5, 2011
Last Updated: August 5, 2011
Health Authority: Turkey: Ethics Committee

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

ClinicalTrials.gov processed this record on July 24, 2014