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

NCT01531192 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2013-07-16

No results posted yet for this study

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.

Conditions

  • Very Low Birth Weight Infants

Interventions

DIETARY_SUPPLEMENT

Lactobacillus reuteri

Lactobacillus reuteri 100 million CFU/day for 3 months

DRUG

Nystatin

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

Sponsors & Collaborators

  • Zekai Tahir Burak Women's Health Research and Education Hospital

    lead OTHER

Principal Investigators

  • Mehmet Yekta Oncel, MD · Neonatology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01531192 on ClinicalTrials.gov