Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
This study is currently recruiting participants.
Verified July 2011 by Zekai Tahir Burak Maternity and Teaching Hospital
Sponsor:
Zekai Tahir Burak Maternity and Teaching Hospital
Information provided by:
Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01411748
First received: August 5, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
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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:
MedlinePlus related topics:
Birth Weight
Drug Information available for:
Nystatin
U.S. FDA Resources
Further study details as provided by Zekai Tahir Burak Maternity and Teaching 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
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 Maternity and Teaching 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 May 23, 2013