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Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants

Information source: Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Very Low Birth Weight Infants

Intervention: Lactobacillus reuteri (Dietary Supplement); Nystatin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Zekai Tahir Burak Women's Health Research and Education Hospital

Official(s) and/or principal investigator(s):
Mehmet Yekta Oncel, MD, Principal Investigator, Affiliation: Neonatology

Summary

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

Clinical Details

Official title: Zekai Tahir Burak Maternity Teaching Hospital, Ankara/Turkey

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants

Secondary outcome:

Effect of Lactobacillus reuteri on feeding intolerance

Effect of Lactobacillus reuteri on sepsis

Effect of Lactobacillus reuteri on length of hospital stay

Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants

Eligibility

Minimum age: N/A. Maximum age: 6 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Very low birth weight infants < 1500 gr

- Gestational age < 32 weeks

Exclusion Criteria:

- Genetic anomalies

- Short bowel syndrome

- Not willing to participate

- Allergy to Lactobacillus reuteri components

Locations and Contacts

Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology, Ankara 06110, Turkey
Additional Information

Lactobacillus reuteri

Nystatin

Starting date: June 2012
Last updated: July 13, 2013

Page last updated: August 23, 2015

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