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

Zekai Tahir Burak Maternity Teaching Hospital, Ankara/Turkey

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01531192

Enrollment

300

Registered

2012-02-10

Start date

2012-06-30

Completion date

2013-04-30

Last updated

2013-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very Low Birth Weight Infants

Keywords

Lactobacillus reuteri, Nystatin, Very Low Birth Weight Infants, Candida Colonization

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus reuteri

Lactobacillus reuteri 100 million CFU/day for 3 months

DRUGNystatin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

1 Days to 6 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026