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

Study Overview
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Brief Summary
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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.

Official Title
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Zekai Tahir Burak Maternity Teaching Hospital, Ankara/Turkey

Conditions
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Very Low Birth Weight Infants

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri
* Drug: Nystatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus reuteri<br>Lactobacillus reuteri 100 million CFU/day for 3 months | Dietary Supplement: Lactobacillus reuteri<br>* Lactobacillus reuteri 100 million CFU/day for 3 months<br>* Other names: BioGaia;|
| Active Comparator: Nystatin<br>50000 unit/3 times a day | Drug: Nystatin<br>* 50000 unit/3 times a day, both for orally and by orogastric route<br>* Other names: Mikostatin;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactobacillus reuteri, Nystatin, Very Low Birth Weight Infants, Candida Colonization