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

Phase 4

Completed

• Conditions: Very Low Birth Weight Infants
• Interventions: Dietary Supplement: Lactobacillus reuteri; Drug: Nystatin

• Registration Number: NCT01531192
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-02
• Study First Submitted: 2012-02-04
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Study Start: 2012-06
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-07-13
• Last Update Posted: 2013-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus reuteri	Lactobacillus reuteri	Lactobacillus reuteri 100 million CFU/day for 3 months
Nystatin	Nystatin	50000 unit/3 times a day

Primary Outcome Measures

Name	Time	Method
Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants	up to 6 months	Rectal and skin swabs for Candida colonization will be taken weekly. Blood culture for Candida infection will be taken weekly.

Secondary Outcome Measures

Name	Time	Method
Effect of Lactobacillus reuteri on feeding intolerance	up to 6 months	Feeding intolerance (gastric residuals in the amount that was more than half of the previous feeding, abdominal distention or heme-positive stools)
Effect of Lactobacillus reuteri on sepsis	up to 6 months	Patients with culture positivity will accept as proven sepsis.
Effect of Lactobacillus reuteri on length of hospital stay	up to 6 months	Specified length of hospital stay as days.
Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants	up to 6 months	NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group.

Trial Locations

Locations (1)

Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology; 🇹🇷 Ankara, Turkey