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

NCT ID: NCT01411748

Last Updated: 2011-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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S. boulardii

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

Group Type EXPERIMENTAL

Reflor

Intervention Type DIETARY_SUPPLEMENT

5 million unit/day, orally, beginning on the second day of life, until discharge from hospital

nystatin

Group Type ACTIVE_COMPARATOR

mikostatin

Intervention Type DRUG

50000 unit/3 times a day, both for orally and by orogastric route

Interventions

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mikostatin

50000 unit/3 times a day, both for orally and by orogastric route

Intervention Type DRUG

Reflor

5 million unit/day, orally, beginning on the second day of life, until discharge from hospital

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Very low birth weight infants \< 1500 gr

Exclusion Criteria

* Genetic anomalies
* Not willing to participate
* Allergy to S. boulardii components
Minimum Eligible Age

1 Day

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zekai Tahir Burak Maternity and Teaching Hospital

Locations

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Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Gamze Demirel, MD

Role: primary

+905324540156

References

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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.

Reference Type BACKGROUND
PMID: 17317426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20706577 (View on PubMed)

Other Identifiers

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demirel98

Identifier Type: -

Identifier Source: org_study_id

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